LongBench v2 / 66fa6867bb02136c067c6b3b / Based on the press release about Sanofi's product Dupixent, how do you know…

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Press Release 
 
 
Dupixent is the first and only biologic to achieve 
significant improvements in disease remission and 
symptoms in bullous pemphigoid positive pivotal study 
 
• 
Study met the primary and all key secondary endpoints in adults with moderate-to-
severe disease; five times more patients achieved sustained disease remission with 
Dupixent than placebo 
• 
Dupixent is the first medicine to show significant steroid-sparing effect in this 
debilitating and life-threatening disease  
• 
If approved, Dupixent would be the first and only targeted medicine to treat BP in the 
U.S. and European Union 
 
Paris and Tarrytown, NY, September 11, 2024. A Dupixent (dupilumab) pivotal study 
(ADEPT) in bullous pemphigoid (BP) met the primary and all key secondary endpoints 
evaluating its investigational use in adults with moderate-to-severe disease. In the study, 
five times more Dupixent patients achieved sustained disease remission compared to those 
on placebo. Sustained disease remission was defined as complete clinical remission with 
completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue 
therapy use during the 36-week treatment period. Dupixent was previously granted Orphan 
Drug Designation by the U.S. Food and Drug Administration for BP, which applies to 
investigational medicines intended for the treatment of rare diseases that affect fewer than 
200,000 people in the U.S. This study will support regulatory submissions around the world, 
starting with the U.S. later this year. 
 
BP, a chronic and relapsing disease, is characterized by intense itch and blisters, reddening 
of the skin, and painful chronic lesions. The blisters and rash can form over much of the 
body and cause the skin to bleed and crust, resulting in patients being more prone to 
infection and affecting their daily functioning.  
 
Dietmar Berger, M.D., Ph.D. 
Chief Medical Officer, Global Head of Development at Sanofi 
“The itchy blisters caused by bullous pemphigoid can be so intense they are debilitating, especially 
for elderly patients. There is a significant unmet medical need for new medicines for people suffering 
with this hard-to-treat disease in which the standard of care is oral and topical corticosteroids and 
immunosuppressants – treatments that have poor clinical outcomes and safety concerns, 
respectively, and should be used sparingly in an elderly population. These positive pivotal results for 
bullous pemphigoid add to an immense body of scientific evidence that underscores the important 
role IL4 and IL13 play in driving diseases characterized by itch. Combined with the consistent safety 
profile of the other dermatology indications, these results show the potential of Dupixent to 
transform the treatment paradigm for bullous pemphigoid.” 
 
In the ADEPT study, 106 adults with moderate-to-severe BP were randomized to receive 
Dupixent 300 mg (n=53) every two weeks after an initial loading dose or placebo (n=53), 


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along with standard-of-care OCS. During treatment, all patients underwent a protocol-
defined OCS tapering regimen if control of disease activity was maintained.  
 
For the primary endpoint, 20% of Dupixent patients experienced sustained disease 
remission at 36 weeks compared to 4% for placebo (p=0.0114). For the components 
comprising the primary endpoint – with patients having to achieve all components – efficacy 
among patients receiving Dupixent compared to placebo was as follows*: 
 
• 
Absence of disease relapse after patient completed OCS taper: 59% vs. 16% 
(nominal p=0.0023) 
• 
Absence of need for rescue therapy during treatment period: 42% vs. 12% (nominal 
p=0.0004) 
• 
Achievement of complete remission and off OCS by week 16: 38% vs. 27% (not 
significant) 
 
*Components were not separately included in pre-specified statistical analyses and are 
therefore nominal 
 
For selected secondary endpoints, results for Dupixent compared to placebo were 
statistically significant as follows:  
• 
Patients achieving ≥90% reduction in disease severity: 41% vs. 10% (p=0.0003) 
• 
Patients achieving clinically meaningful itch reduction: 40% vs. 11% (p=0.0006) 
• 
Secondary endpoints assessing decreased OCS use, and time to use of rescue 
medications, also favored Dupixent and were significant (p=0.0220 and p=0.0016, 
respectively) 
• 
Reduction in disease severity from baseline: 77% vs. 51% (p=0.0021) 
• 
Reduction in itch from baseline: 52% vs. 27% (p=0.0021) 
• 
Days of complete remission off OCS: 40 vs. 13 (p=0.0072) 
 
In this older population, overall rates of adverse events (AEs) were 96% (n=51) for 
Dupixent and 96% (n=51) for placebo. AEs more commonly observed with Dupixent 
compared to placebo in more than 3 patients included peripheral edema (n=8 vs. n=5), 
arthralgia (n=5 vs. n=3), back pain (n=4 vs. n=2), blurred vision (n=4 vs. n=0), 
hypertension (n=4 vs. n=3), asthma (n=4 vs. n=1), conjunctivitis (n=4 vs. n=0), 
constipation (n=4 vs. n=1), upper respiratory tract infection (n=3 vs. n=1), limb injury 
(n=3 vs. n=2), and insomnia (n=3 vs. n=2). There were no AEs leading to death in the 
Dupixent group and 2 AEs leading to death in the placebo group. 
 
George D. Yancopoulos, M.D., Ph.D. 
Board co-Chair, President, and Chief Scientific Officer at Regeneron  
“Bullous pemphigoid is a debilitating skin disease with a high mortality rate due to infection. 
Dupixent is the first medication to show significant and robust impacts in this patient population. 
These latest pivotal results reaffirm the underlying role type-2 inflammation plays in driving 
multiple skin diseases. We look forward to further advancing this research and sharing the positive 
results from the bullous pemphigoid pivotal trial with regulatory authorities.”  
 
Additionally, a small separate phase 3 study (Study A) evaluating the investigational use of 
Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin (CPUO) 
did not achieve statistical significance in its primary itch responder endpoint (despite 
favorable numerical improvements), but showed nominally significant improvements in all 


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other itch endpoints including: change from baseline; percent of patients achieving no/mild 
itch; and change in itch-related quality of life from baseline. Safety results were generally 
consistent with the known safety profile of Dupixent in its approved dermatological 
indications. The Dupixent phase 3 study program in CPUO consists of Study A and Study B. 
Study B is planned to initiate as a subsequent pivotal study. 
Detailed efficacy and safety results for both BP and CPUO studies are planned for 
presentation at a forthcoming medical meeting. 
 
The safety and efficacy of Dupixent in BP and CPUO are currently under clinical investigation 
and have not been evaluated by any regulatory authority. 
 
About the Dupixent BP pivotal study  
ADEPT is a randomized, phase 2/3, double-blind, placebo-controlled study evaluating the 
efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week 
treatment period. After randomization, patients received Dupixent or placebo every two 
weeks, with OCS treatment. During treatment, OCS taper was initiated after patients 
experienced two weeks of sustained control of disease activity. OCS tapering could start 
between four to six weeks after randomization and was continued as long as disease control 
was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients 
were only treated with Dupixent or placebo for at least 20 weeks, unless rescue treatment 
was required. 
 
The primary endpoint evaluated the proportion of patients achieving sustained disease 
remission at 36 weeks. Sustained disease remission was defined as complete clinical 
remission with completion of OCS taper by 16 weeks without relapse and no rescue therapy 
use during the 36-week treatment period. Relapse was defined as appearance of ≥3 new 
lesions a month or ≥1 large lesion (>10cm in diameter) that did not heal within a week. 
Rescue therapy could include treatment with high-potency topical corticosteroids, OCS 
(including increase of OCS dose during the taper or re-initiation of OCS after completion of 
the OCS taper), systemic non-steroidal immunosuppressive medications, or 
immunomodulating biologics. 
 
Select secondary endpoints evaluated at 36 weeks included: 
• 
Proportion of patients achieving ≥90% reduction in Bullous Pemphigoid Disease Area 
Index (BPDAI; scale:0-360) 
• 
Proportion of patients with ≥4-point reduction in Peak Pruritus Numerical Rating 
Scale (PP-NRS; scale 0-10) 
• 
Total cumulative OCS dose 
• 
Time to first use of rescue medication 
• 
Percent change from baseline in BPDAI 
• 
Percent change in weekly average of daily PP-NRS 
• 
Duration of complete remission while not requiring OCS 
 
About the Dupixent CPUO phase 3 program 
The Dupixent phase 3 program in CPUO consists of Study A and Study B. Study A was a 
randomized, phase 3, double-blind, placebo-controlled study evaluating the efficacy and 
safety of Dupixent in adults with uncontrolled, severe CPUO. During the 4-week run-in 
period, patients received a standard-of-care regimen comprised of a non-sedative 
antihistamine and moisturizer to confirm they were refractory to available options. During 


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the following 24-week treatment period, patients received Dupixent or placebo every two 
weeks added to the standard-of-care regimen. 
 
The primary endpoint evaluated the proportion of patients with a clinically meaningful 
improvement in itch from baseline at 24 weeks, measured by a ≥4-point reduction in the 
worst-itch numerical rating scale (WI-NRS; scale: 0-10). The key secondary endpoint 
evaluated the proportion of patients with a ≥4-point reduction in WI-NRS at 12 weeks. 
Additional secondary endpoints included: 
• 
Proportion of patients achieving no/mild pruritus on Patient Global Impression of 
Severity (PGIS) of pruritus 
• 
Absolute change and percent change from baseline in the weekly average of daily 
itch-related sleep disturbances at 24 weeks measured by the sleep disturbance NRS 
(scale: 0-10) 
• 
Absolute change from baseline in itch-related quality of life measured by the 
ItchyQoL (scale: 22-110)  
• 
Absolute change from baseline in health-related quality of life at 24 weeks measured 
by the Dermatology Life Quality Index (scale: 0-30) 
 
Study B is planned to initiate as a subsequent pivotal study. 
 
About Dupixent 
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the 
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. 
The Dupixent development program has shown significant clinical benefit and a decrease in 
type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central 
drivers of the type-2 inflammation that plays a major role in multiple related and often co-
morbid diseases. 
 
Dupixent has received regulatory approvals in more than 60 countries in one or more 
indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis 
with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous 
urticaria, and chronic obstructive pulmonary disease in different age populations. More than 
1,000,000 patients are being treated with Dupixent globally. 
 
Dupilumab development program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration 
agreement. To date, dupilumab has been studied across more than 60 clinical studies 
involving more than 10,000 patients with various chronic diseases driven in part by type-2 
inflammation. 
 
In addition to the currently approved indications, Sanofi and Regeneron are studying 
dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic 
processes in phase 3 studies, including chronic pruritus of unknown origin and bullous 
pemphigoid. These potential uses of dupilumab are currently under clinical investigation, 
and the safety and efficacy in these conditions have not been fully evaluated by any 
regulatory authority. 
 
About Regeneron 
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and 
commercializes life-transforming medicines for people with serious diseases. Founded and 


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led by physician-scientists, our unique ability to repeatedly and consistently translate 
science into medicine has led to numerous approved treatments and product candidates in 
development, most of which were homegrown in our laboratories. Our medicines and 
pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, 
cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic 
conditions, infectious diseases, and rare diseases. 
 
Regeneron pushes the boundaries of scientific discovery and accelerates drug 
development using our proprietary technologies, such as VelociSuite®, which produces 
optimized fully human antibodies and new classes of bispecific antibodies. We are shaping 
the next frontier of medicine with data-powered insights from the Regeneron Genetics 
Center® and pioneering genetic medicine platforms, enabling us to identify innovative 
targets and complementary approaches to potentially treat or cure diseases. 
 
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, 
Instagram, Facebook or X. 
 
About Sanofi  
We are an innovative global healthcare company, driven by one purpose: we chase the 
miracles of science to improve people’s lives. Our team, across the world, is dedicated to 
transforming the practice of medicine by working to turn the impossible into the possible. 
We provide potentially life-changing treatment options and life-saving vaccine protection to 
millions of people globally, while putting sustainability and social responsibility at the center 
of our ambitions. 
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 
 
Sanofi Media Relations 
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Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com 
 
Sanofi Investor Relations 
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Regeneron Media Relations 
Ilana Yellen | +1 914-330-9618| ilana.yellen@regeneron.com  
  
Regeneron Investor Relations 
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Sanofi Forward-Looking Statements 
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as 
amended. Forward-looking statements are statements that are not historical facts. These statements include projections and 
estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to 
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forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to 
various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause 


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actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking 
information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and 
development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the 
EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product 
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other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of 
any one of them, as well as on our employees and on the global economy as a whole.  The risks and uncertainties also include the 
uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 
“Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the 
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revise any forward-looking information or statements. 
 
All trademarks mentioned in this press release are the property of the Sanofi group apart from VelociSuite and Regeneron Genetics 
Center. 
 
Regeneron Forward-Looking Statements and Use of Digital Media  
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 
performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ 
materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” 
“estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not 
all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties 
include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise 
commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates 
being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research 
and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab); the likelihood, timing, and 
scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for 
Regeneron’s Products, such as Dupixent for the treatment of bullous pemphigoid and/or chronic pruritus of unknown origin as 
discussed in this press release as well as other potential indications; uncertainty of the utilization, market acceptance, and 
commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by 
Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on 
any of the foregoing or any potential regulatory approval of Regeneron’s Products (such as Dupixent) and Regeneron’s Product 
Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its 
collaborators or licensees (including the studies discussed or referenced in this press release) may be replicated in other studies 
and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the ability of 
Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, 
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of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration 
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of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related 
proceedings relating to EYLEA® (aflibercept) Injection), other litigation and other proceedings and government investigations 
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Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and 
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Regeneron uses its media and investor relations website and social media outlets to publish important information about the 
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LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). 
 


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Press Release 
 
 
Dupixent phase 3 study confirms significant 
improvements in itch and hives for patients with CSU  
 
• 
Confirming the results of CUPID-A, this second pivotal study in biologic-naïve 
patients met primary and key secondary endpoints, showing treatment with 
Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores  
• 
More than 300,000 people in the US suffer from chronic spontaneous urticaria 
(CSU) that is inadequately controlled by antihistamines 
• 
Data will support regulatory resubmission in the US by year-end; if approved, 
Dupixent would be the first targeted therapy for CSU in a decade 
Paris and Tarrytown, NY, September 11, 2024. A Dupixent (dupilumab) confirmatory 
phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for 
the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving 
background therapy with antihistamines. CSU is a chronic skin condition that causes sudden 
and debilitating hives and persistent itch, which can impact quality of life. This positive 
study confirms results from Study A, the first phase 3 study of Dupixent in this setting. 
Earlier this year, Japan was the first country in the world to approve and launch Dupixent 
for adult and adolescent CSU patients based on the results from Study A. 
Dietmar Berger, M.D., Ph.D. 
Chief Medical Officer, Global Head of Development at Sanofi 
“The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment 
option for the many people suffering from chronic spontaneous urticaria who do not respond to 
standard-of-care antihistamines. With clinically meaningful reductions in itch and hives for patients 
receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients 
with CSU in the US as soon as possible. With Dupixent now treating 1 million patients across seven 
approved indications, these new results underscore there are still many more patients that Dupixent 
can potentially benefit.” 
 
Study C enrolled 151 children and adults randomized to receive Dupixent (n=74) or placebo 
(n=77) added to standard-of-care histamine-1 (H1) antihistamines. At 24 weeks, efficacy 
among patients receiving Dupixent compared to placebo was as follows:  
 
• 
8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point 
reduction with placebo (p=0.02) 
• 
15.86-point reduction in urticaria activity (itch and hive) severity from baseline with 
Dupixent versus an 11.21-point reduction with placebo (p=0.02) 
 
Notably, 30% of Dupixent-treated patients reported no urticaria (complete response), 
compared to 18% of those on placebo (p=0.02). 
 
The safety results were generally consistent with the known safety profile of Dupixent in its 
approved dermatological indications. Overall rates of treatment emergent adverse events 


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(AE) were 53% for Dupixent and 53% for placebo. AEs more commonly observed with 
Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), 
accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%). 
 
Detailed results from this study will be provided to the US Food and Drug Administration in 
response to the additional data requested for inclusion in the supplemental biologics 
application for Dupixent in CSU. These data are also planned for presentation at a 
forthcoming medical meeting. 
 
George D. Yancopoulos, M.D., Ph.D. 
Board Co-Chair, President, and Chief Scientific Officer at Regeneron  
“Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that 
appear without warning and disrupt their lives. With a nearly 50% reduction in itch and urticaria 
activity scores compared to placebo, these positive phase 3 results reaffirm the potential of Dupixent 
to bring relief and its well-established safety profile to those living with this chronic inflammatory 
skin disease.”  
 
Outside of Japan, the safety and efficacy of Dupixent for CSU has not been fully evaluated 
by any regulatory authority. 
 
About CSU 
CSU is a chronic inflammatory skin disease driven in part by type-2 inflammation, which 
causes sudden and debilitating hives and persistent itch. CSU is typically treated with H1 
antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. 
However, the disease remains uncontrolled despite antihistamine treatment in many 
patients, some of whom are left with limited alternative treatment options. These individuals 
continue to experience symptoms that can be debilitating and significantly impact their 
quality of life. 
 
About the Dupixent phase 3 CSU program (LIBERTY-CUPID) 
The LIBERTY-CUPID Phase 3 study program evaluating Dupixent in CSU consists of Study A, 
Study B, and Study C.  
 
Study C was a randomized, double-blind, placebo-controlled clinical study that evaluated 
the efficacy and safety of Dupixent as an add-on to standard-of-care antihistamines 
compared to antihistamines alone in 151 patients aged six years and older with CSU who 
remained symptomatic despite antihistamine use and were not previously treated with 
omalizumab (i.e., biologic-naïve). The primary endpoint assessed the change from baseline 
in itch at 24 weeks (measured by the weekly itch severity score [ISS7], 0-21 scale). A key 
secondary endpoint was the change from baseline in itch and hives at 24 weeks (measured 
by the weekly urticaria activity score [UAS7], 0-42 scale). 
 
Study A supported the approval of Dupixent in Japan for the treatment of CSU in people 
aged 12 years and older whose disease is not adequately controlled with existing therapy. 
 
Results from Study A and Study B, which assessed Dupixent in patients aged 12 years and 
older who were uncontrolled on standard-of-care H1 antihistamines and refractory to 
omalizumab, were published in The Journal of Allergy and Clinical Immunology. 
 
About Dupixent 


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Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the 
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. 
The Dupixent development program has shown significant clinical benefit and a decrease in 
type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central 
drivers of the type-2 inflammation that plays a major role in multiple related and often co-
morbid diseases. 
 
Dupixent has received regulatory approvals in more than 60 countries in one or more 
indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis 
with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic 
obstructive pulmonary disease in different age populations. More than 1,000,000 patients 
are being treated with Dupixent globally. 
 
Dupilumab development program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration 
agreement. To date, dupilumab has been studied across more than 60 clinical studies 
involving more than 10,000 patients with various chronic diseases driven in part by type-2 
inflammation. 
 
In addition to the currently approved indications, Sanofi and Regeneron are studying 
dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic 
processes in phase 3 studies, including chronic pruritus of unknown origin and bullous 
pemphigoid. These potential uses of dupilumab are currently under clinical investigation, 
and the safety and efficacy in these conditions have not been fully evaluated by any 
regulatory authority. 
 
About Regeneron 
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and 
commercializes life-transforming medicines for people with serious diseases. Founded and 
led by physician-scientists, our unique ability to repeatedly and consistently translate 
science into medicine has led to numerous approved treatments and product candidates in 
development, most of which were homegrown in our laboratories. Our medicines and 
pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, 
cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic 
conditions, infectious diseases, and rare diseases. 
 
Regeneron pushes the boundaries of scientific discovery and accelerates drug 
development using our proprietary technologies, such as VelociSuite®, which produces 
optimized fully human antibodies and new classes of bispecific antibodies. We are shaping 
the next frontier of medicine with data-powered insights from the Regeneron Genetics 
Center® and pioneering genetic medicine platforms, enabling us to identify innovative 
targets and complementary approaches to potentially treat or cure diseases. 
 
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, 
Instagram, Facebook or X. 
 
About Sanofi  
We are an innovative global healthcare company, driven by one purpose: we chase the 
miracles of science to improve people’s lives. Our team, across the world, is dedicated to 
transforming the practice of medicine by working to turn the impossible into the possible. 


4/5 
4/5 
 
 
 
 
 
 
 
We provide potentially life-changing treatment options and life-saving vaccine protection to 
millions of people globally, while putting sustainability and social responsibility at the center 
of our ambitions. 
 
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 
 
Sanofi Media Relations 
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com 
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com 
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com 
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com 
 
Sanofi Investor Relations 
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com 
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com 
Arnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com 
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com 
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com 
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com 
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com 
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com 
 
Regeneron Media Relations 
Ilana Yellen | +1 914-330-9618| ilana.yellen@regeneron.com  
  
Regeneron Investor Relations 
Vesna Tosic | + 914-847-5443 | vesna.tosic@regeneron.com 
 
Sanofi forward-looking statements 
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding 
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements 
are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. 
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors 
are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are 
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially 
from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties 
include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the 
availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent 
in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post 
marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and 
any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact 
that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the 
financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties 
also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those 
listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-
F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to 
update or revise any forward-looking information or statements. 
 
All trademarks mentioned in this press release are the property of the Sanofi group apart from VelociSuite and Regeneron Genetics 
Center. 
 
Regeneron Forward-Looking Statements and Use of Digital Media  
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 
performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ 
materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” 
“estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although 
not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties 
include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise 
commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates 
being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research 
and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab); the likelihood, timing, and 
scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for 
Regeneron’s Products, such as Dupixent for the treatment of chronic spontaneous urticaria (“CSU”) as discussed in this press 
release as well as other potential indications; uncertainty of the utilization, market acceptance, and commercial success of 


5/5 
5/5 
 
 
 
 
 
 
 
Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others 
and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or 
any potential regulatory approval of Regeneron’s Products (such as Dupixent for the treatment of CSU) and Regeneron’s Product 
Candidates; whether the results from the confirmatory Phase 3 trial discussed in this press release will be sufficient for purposes of 
the request from the U.S. Food and Drug Administration for additional data to include in the supplemental biologics application for 
Dupixent in CSU; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform 
manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s 
Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues 
resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, 
including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product 
Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict 
Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing 
regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those 
relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including 
private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, 
and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new 
policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost 
effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and 
development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead 
to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; 
the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or 
guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or 
supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) 
to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on 
Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating 
thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), 
other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the 
pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of 
Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have 
on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other 
material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for 
the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-looking 
statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any 
forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) 
any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new 
information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to 
publish important information about the Company, including information that may be deemed material to investors. Financial and 
other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website 
(https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). 
 


1/4 
1/4 
 
 
 
 
 
Press Release 
 
 
 
Dupixent recommended for EU approval by the CHMP to 
treat eosinophilic esophagitis in children as young as 1 
year old  
 
* 
Recommendation based on a phase 3 study showing a significantly greater proportion 
of children on Dupixent achieved histological remission, compared to placebo, 
consistent with improvements seen in adults and adolescents 
* 
If approved, Dupixent would be the first and only medicine in the EU indicated for EoE 
in this age group 
 
Paris and Tarrytown, NY, September 20, 2024. The European Medicines Agency’s 
Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion 
recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) 
for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is 
for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled 
by, intolerant to, or who are not candidates for conventional medicinal therapy. The European 
Commission is expected to announce a final decision in the coming months. Dupixent is 
already approved in the EU for certain adults and adolescents aged 12 years and older with 
EoE. 
 
The positive CHMP opinion is supported by a two-part (Part A and B) EoE KIDS phase 3 study 
in children aged one to 11 years. In Part A, a significantly greater proportion of children 
receiving weight-based doses of Dupixent achieved histological disease remission at week 16, 
compared to placebo, with results sustained for up to one year in Part B. At week 16, 
caregivers of children treated with Dupixent also observed improvements in the frequency 
and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. 
These data established a bridge showing the response to Dupixent in children with EoE is 
similar to that of the approved adult and adolescent EoE populations.  
 
The safety results in the EoE KIDS study were generally consistent with the known safety 
profile of Dupixent in adolescents and adults with EoE. AEs more commonly observed with 
Dupixent (≥10%) in either weight-based dosing regimen compared to placebo during Part A 
were COVID-19, nausea, injection site pain and headache. The long-term safety profile of 
Dupixent evaluated in Part B was similar to that observed during Part A.  
 
Results from the study were recently published in The New England Journal of Medicine. 
 
The use of Dupixent in children aged one to 11 years with EoE is investigational in the EU and 
is not yet approved.  
 
 
About EoE 


2/4 
2/4 
 
 
 
 
 
EoE is a chronic, progressive disease associated with type-2 inflammation that is thought to 
be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, 
as symptoms can be mistaken for other conditions and there are delays in diagnosis. EoE can 
severely impact a child’s ability to eat and may also cause vomiting, abdominal pain, difficulty 
swallowing, decreased appetite and challenges thriving. Continuous management of EoE may 
be needed to reduce the risk of complications and disease progression. 
 
About Dupixent 
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the 
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The 
Dupixent development program has shown significant clinical benefit and a decrease in type-
2 inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers 
of the type-2 inflammation that plays a major role in multiple related and often co-morbid 
diseases. 
 
Dupixent has received regulatory approvals in more than 60 countries in one or more 
indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis 
with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic 
obstructive pulmonary disease in different age populations. More than 1,000,000 patients are 
being treated with Dupixent globally. 
 
Dupilumab development program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration 
agreement. To date, dupilumab has been studied across more than 60 clinical studies 
involving more than 10,000 patients with various chronic diseases driven in part by type-2 
inflammation. 
 
In addition to the currently approved indications, Sanofi and Regeneron are studying 
dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic 
processes in phase 3 studies, including chronic pruritus of unknown origin and bullous 
pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and 
the safety and efficacy in these conditions have not been fully evaluated by any regulatory 
authority. 
 
About Regeneron  
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and 
commercializes life-transforming medicines for people with serious diseases. Founded and led 
by physician-scientists, our unique ability to repeatedly and consistently translate science into 
medicine has led to numerous approved treatments and product candidates in development, 
most of which were homegrown in our laboratories. Our medicines and pipeline are designed 
to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular 
and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, 
and rare diseases.  
 
Regeneron pushes 
the 
boundaries 
of 
scientific 
discovery 
and accelerates 
drug 
development using our proprietary technologies, such as VelociSuite®, which produces 
optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the 
next frontier of medicine with data-powered insights from the Regeneron Genetics 
Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets 
and complementary approaches to potentially treat or cure diseases. 


3/4 
3/4 
 
 
 
 
 
 
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, 
Instagram, Facebook or X. 
 
 
About Sanofi  
We are an innovative global healthcare company, driven by one purpose: we chase the 
miracles of science to improve people’s lives. Our team, across the world, is dedicated to 
transforming the practice of medicine by working to turn the impossible into the possible. We 
provide potentially life-changing treatment options and life-saving vaccine protection to 
millions of people globally, while putting sustainability and social responsibility at the center 
of our ambitions.  
 
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 
 
Sanofi Media Relations 
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com 
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com 
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com 
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com 
 
Sanofi Investor Relations 
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com 
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com 
Arnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com 
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com 
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com 
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com 
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com 
 
 
Regeneron Media Relations 
Hannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com 
 
Regeneron Investor Relations 
Vesna Tosic | + 914-847-5443 | vesna.tosic@regeneron.com 
 
 
 
 
Sanofi forward-looking statements 
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding 
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements 
are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. 
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors 
are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are 
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially 
from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties 
include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the 
availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent 
in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post 
marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and 
any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact 
that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the 
financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties 
also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those 
listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-
F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to 
update or revise any forward-looking information or statements. 


4/4 
4/4 
 
 
 
 
 
 
All trademarks mentioned in this press release are the property of the Sanofi group with the exception of VelociSuite and Regeneron 
Genetics Center. 
 
Regeneron Forward-Looking Statements 
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 
performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially 
from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” 
variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-
looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among 
others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by 
Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by 
Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs 
now underway or planned, including without limitation Dupixent® (dupilumab); the impact of the opinion adopted by the European 
Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the 
European Commission of Dupixent to treat eosinophilic esophagitis (“EoE”) in children aged 1 to 11 years; the likelihood, timing, and 
scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s 
Products, such as Dupixent for the treatment of pediatric EoE in the European Union as discussed in this press release as well as for 
the treatment of chronic pruritus of unknown origin, bullous pemphigoid, and other potential indications; uncertainty of the utilization, 
market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies 
(whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in 
this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as 
applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s 
Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product 
candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product 
Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and 
Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which 
may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product 
Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and 
business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-
party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit 
management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by 
such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior 
to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the 
research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies 
and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated 
expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections 
or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or 
supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) 
to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on 
Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto 
(including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other 
litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending 
civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), 
the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s 
business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be 
found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 
31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-looking statements are made based on 
management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by 
Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including 
without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.  
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, 
including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted 
and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page 
(https://www.linkedin.com/company/regeneron-pharmaceuticals). 
 


1/5 
1/5 
 
 
 
 
 
 
 
Press Release 
 
 
Dupixent approved in China as the first-ever biologic 
medicine for patients with COPD 
 
• 
Approval follows EU approval of Dupixent for adults with COPD with raised blood 
eosinophils, and is based on two landmark phase 3 studies showing Dupixent 
significantly reduced exacerbations, improved lung function, and also improved 
health-related quality of life 
• 
COPD is the most prevalent chronic respiratory disease in China, and is a priority 
within the government’s Healthy China 2030 public health plan   
• 
Dupixent is now approved in four indications across respiratory and 
dermatological diseases in China 
 
Paris and Tarrytown, New York, Sept. 27, 2024. The National Medical Products 
Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on 
maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease 
(COPD) characterized by raised blood eosinophils. Specifically, the approval covers patients 
already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist 
(LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and 
a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has been approved in 
more than 30 countries worldwide, including the 27 countries in the EU. 
 
Professor Kang Jian  
Chair of COPD Branch, Chinese Association of Chest Physicians, CMDA, Respiratory 
Department of First Hospital of China Medical University 
“The impact of COPD extends far beyond the patient. Debilitating breathlessness and 
irreversible lung damage make it difficult for patients to do simple daily tasks, placing a 
significant burden on family members, the central caregivers in Chinese families. The approval 
of Dupixent for COPD in China is critical, as it fills a gap in targeted therapy for the disease and 
provides clinicians with a new treatment approach. This offers new hope for COPD patients who 
remain inadequately controlled even after triple therapy, as well as those who care for them." 
 
Houman Ashrafian, MD, PhD  
Executive Vice President, Head of Research and Development at Sanofi  
“China has the largest number of people living with COPD worldwide, and a significant 
proportion of patients are uncontrolled on current therapies and desperate for an effective 
treatment option. The Dupixent COPD clinical program has furthered our scientific 
understanding of COPD, and given us a new way to think about which patients could benefit 
most from such a treatment. With its well-established safety and efficacy profile, Dupixent is a 
long-awaited advancement for patients, caregivers, and physicians who are desperate for a 
new treatment option.” 
 
Despite the high prevalence and burden of COPD in China, public awareness is limited. The 
Healthy China 2030 public health initiative includes a focus on addressing chronic respiratory 
diseases like COPD and aims to improve the quality of life for patients with COPD.  


2/5 
2/5 
 
 
 
 
 
 
 
 
The approval is based on results from the landmark BOREAS and NOTUS phase 3 studies, 
which evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with 
raised blood eosinophils. All patients were on background maximal standard-of-care inhaled 
therapy (nearly all on triple therapy). Dupixent significantly reduced COPD exacerbations by 
30% and 34% compared to placebo in the BOREAS and NOTUS studies respectively. Dupixent 
significantly and rapidly improved lung function compared to placebo, with improvements 
sustained at 52 weeks. Improvements in health-related quality of life (statistically significant 
in BOREAS and nominally significant in NOTUS) compared to placebo were also observed, as 
assessed by the St. George’s Respiratory Questionnaire (SGRQ). Data from both studies were 
published in separate manuscripts in The New England Journal of Medicine (BOREAS and 
NOTUS). 
 
Safety results in both studies were generally consistent with the known safety profile of 
Dupixent in its approved indications. The most common side effects across indications include 
injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and 
eosinophilia. Additional adverse reactions of injection site bruising, injection site induration, 
injection site rash, and injection site dermatitis were reported in the COPD studies. Adverse 
events more commonly observed with Dupixent (≥5%) compared to placebo in either COPD 
study were back pain, COVID-19, diarrhea, headache, and nasopharyngitis.  
 
George D. Yancopoulos, M.D., Ph.D. 
Board co-Chair, President, and Chief Scientific Officer at Regeneron  
“One in four people with COPD live in China, and many patients are unable to control their 
disease with standard of care treatments and experience repeated hospitalizations from 
exacerbations and debilitating limitations on their quality of life. With millions of people in 
industrialized areas worldwide facing increased risk for developing COPD, it is more important 
than ever to deliver innovative new options for this complex and notoriously difficult-to-treat 
disease. With this latest Dupixent approval, patients in China have a novel treatment approach 
that has shown groundbreaking results by reducing exacerbations while also improving lung 
function and supporting a better quality of life.” 
 
Additional submissions for Dupixent in COPD are under review with regulatory authorities 
around the world, including in the US and Japan. 
 
About COPD 
COPD is a respiratory disease that damages the lungs and causes progressive lung function 
decline. Symptoms include persistent cough, excessive mucus production, and shortness of 
breath that may impair the ability to perform routine daily activities, which may lead to sleep 
disturbances, anxiety and depression. COPD is also associated with a significant health and 
economic burden due to recurrent acute exacerbations that require systemic corticosteroid 
treatment and/or lead to hospitalization. Smoking and exposure to noxious particles are key 
risk factors for COPD, but even individuals who quit smoking can still have progressive lung 
disease.  
 
About half of COPD patients continue to experience exacerbations despite being on triple 
inhaled therapy. Patients with an eosinophilic phenotype contribute to a ~30% increase in 
exacerbations and an increased risk of COPD-related re-hospitalizations within a year. 
 
 
 


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About Sanofi and Regeneron’s COPD Clinical Research Program 
Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by 
examining the role different types of inflammation play in the disease progression through 
the investigation of two potentially first-in-class biologics, Dupixent and itepekimab. 
 
Dupixent inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways 
and the program focuses on a specific population of people with evidence of type-2 
inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits 
interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD. 
 
Itepekimab is currently under clinical investigation for COPD in two phase 3 studies and its 
safety and efficacy have not been evaluated by any regulatory authority. 
 
About Dupixent 
Dupixent is available in China in a 300 mg dose as a pre-filled syringe or pre-filled pen and is 
now available for COPD. Dupixent is intended for injection under the skin (subcutaneous 
injection) and is given every other week. It can be given in a clinic or at home by self-
administration after training by a healthcare professional. 
 
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the 
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The 
Dupixent development program has shown significant clinical benefit and a decrease in type-
2 inflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers 
of the type-2 inflammation that plays a major role in multiple related and often co-morbid 
diseases. 
 
Dupixent has received regulatory approvals in more than 60 countries in one or more 
indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis 
with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, 
and COPD in different age populations. More than 1,000,000 patients are being treated with 
Dupixent globally. 
 
Dupilumab development program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration 
agreement. To date, dupilumab has been studied across more than 60 clinical studies 
involving more than 10,000 patients with various chronic diseases driven in part by type-2 
inflammation. 
 
In addition to the currently approved indications, Sanofi and Regeneron are studying 
dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic 
processes in phase 3 studies, including chronic pruritus of unknown origin and bullous 
pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and 
the safety and efficacy in these conditions have not been fully evaluated by any regulatory 
authority. 
 
About Regeneron 
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and 
commercializes life-transforming medicines for people with serious diseases. Founded and led 
by physician-scientists, our unique ability to repeatedly and consistently translate science into 
medicine has led to numerous approved treatments and product candidates in development, 


4/5 
4/5 
 
 
 
 
 
 
 
most of which were homegrown in our laboratories. Our medicines and pipeline are designed 
to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular 
and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, 
and rare diseases. 
 
Regeneron pushes 
the 
boundaries 
of 
scientific 
discovery 
and accelerates 
drug 
development using our proprietary technologies, such as VelociSuite®, which produces 
optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the 
next frontier of medicine with data-powered insights from the Regeneron Genetics 
Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets 
and complementary approaches to potentially treat or cure diseases. 
 
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, 
Instagram, Facebook or X. 
 
About Sanofi  
We are an innovative global healthcare company, driven by one purpose: we chase the 
miracles of science to improve people’s lives. Our team, across the world, is dedicated to 
transforming the practice of medicine by working to turn the impossible into the possible. We 
provide potentially life-changing treatment options and life-saving vaccine protection to 
millions of people globally, while putting sustainability and social responsibility at the center 
of our ambitions.  
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 
 
Sanofi Media Relations 
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com 
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com 
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com 
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com 
 
Sanofi Investor Relations 
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com 
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com 
Arnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com 
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com 
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com 
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com 
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com 
 
Regeneron Media Relations 
Hannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com   
  
Regeneron Investor Relations 
Vesna Tosic | + 914-847-5443 | vesna.tosic@regeneron.com 
 
 
 
 
Sanofi forward-looking statements 
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding 
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements 
are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. 
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors 
are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are 
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially 


5/5 
5/5 
 
 
 
 
 
 
 
from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties 
include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the 
availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent 
in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post 
marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and 
any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact 
that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the 
financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties 
also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those 
listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-
F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to 
update or revise any forward-looking information or statements. 
 
All trademarks mentioned in this press release are the property of the Sanofi group with the exception of VelociSuite and Regeneron 
Genetics Center. 
 
Regeneron Forward-Looking Statements and Use of Digital Media  
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 
performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially 
from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations 
of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking 
statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the 
nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron 
and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron 
and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway 
or planned, including without limitation Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled 
chronic obstructive pulmonary disease characterized by raised blood eosinophils (“COPD”); uncertainty of the utilization, market 
acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether 
conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press 
release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products (such as Dupixent) and Regeneron’s 
Product Candidates (such as itepekimab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of 
Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as Dupixent for the treatment of COPD in the 
United States, Japan, and other jurisdictions as well as Dupixent for the treatment of chronic pruritus of unknown origin, bullous 
pemphigoid, and other potential indications; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as 
applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s 
Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product 
candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product 
Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regeneron’s 
Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental 
authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and 
Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical 
programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s 
Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, 
pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement 
determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates 
that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which 
the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be 
replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory 
approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of 
its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any 
license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated 
companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the 
COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future 
litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® 
(aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its 
operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office 
for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the 
foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of 
these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its 
Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-
looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any 
forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any 
forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, 
future events, or otherwise.  
 
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, 
including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted 
and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page 
(https://www.linkedin.com/company/regeneron-pharmaceuticals). 


1/6 
 
 
 
 
 
Press Release 
 
 
Dupixent approved in the US as the first-ever biologic 
medicine for patients with COPD 
 
 
• 
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately 
controlled COPD and an eosinophilic phenotype  
• 
Following recent approvals in the EU and China, the US approval is based on two 
landmark phase 3 studies that showed Dupixent achieved significant reduction in 
exacerbations, and also showed improvements in lung function and health-related 
quality of life compared to placebo 
• 
Dupixent is the leading biologic medicine for all of its FDA-approved indications in 
new-to-brand prescriptions, and the most prescribed biologic by pulmonologists in 
the US 
 
Paris and Tarrytown, NY, September 27, 2024. The US Food and Drug Administration 
(FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults 
with inadequately controlled chronic obstructive pulmonary disease (COPD) and an 
eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat 
these patients.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Jean Wright, M.D.
Chief Executive Officer at The COPD Found欧洲净零工业法案ation
“People living with inadequately controlled COPD have long awaited new medicines to help 
manage the daily suffering they experience from breathlessness, coughing, wheezing, 
exhaustion and unpredictable hospitalization. These patients often struggle with everyday 
activities many people take for granted such as taking a walk or running errands outside the 
home. We welcome the approval of this new therapeutic option to offer patients a new way to 
help gain better control of their disease.”
Paul Hudson
Chief Executive Officer at Sanofi
“Dupixent has already shown it can revolutionize the treatment paradigm of many diseases 
driven in part by type 2 inflammation with high unmet medical needs, with one million patients
being treated globally across all currently approved indications. With today’s approval, 
Dupixent once again paves the way and becomes the first and only approved add-on biologic 
medicine for inadequately controlled COPD, giving patients living with this devastating 
disease the chance to look forward to the potential of improved breathing and a life with fewer 
exacerbations.”
The FDA approval is based on data from two landmark pivotal phase 3 studies (BOREAS and 
NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults 
currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with 
inadequately controlled COPD and blood eosinophils ≥300 cells per µL. Patients who 
received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following 
outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):


2/6 
 
 
 
 
 
• 
30% and 34% reduction in the annualized rate of moderate or severe COPD 
exacerbations over 52 weeks, the primary endpoint. 
• 
74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 
from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically 
significant improvements of similar magnitude were observed in pre-bronchodilator 
FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.  
• 
51% response in a health-related quality of life measure in both trials compared to 
43% and 47% with placebo at 52 weeks, as assessed by a 4-point improvement 
on the St. George’s Respiratory Questionnaire (SGRQ). 
 
 
Safety results in both studies were generally consistent with the known safety profile of 
Dupixent in its approved indications. In pooled BOREAS and NOTUS data, the most common 
adverse events (>2%) more frequently observed in patients on Dupixent compared to 
placebo were viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, 
urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache, and 
gastritis. While less common, cholecystitis was reported in 0.6% of patients on Dupixent 
compared to 0.1% of patients on placebo. 
 
George D. Yancopoulos, M.D., Ph.D. 
Board Co-Chair, President and Chief Scientific Officer at Regeneron 
“This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of 
COPD patients in the US who can sometimes struggle just to breathe during their everyday 
lives. Dupixent has a proven track record as a first-in-class medicine, providing benefit to the 
many patients suffering from type 2 inflammatory related diseases such as asthma and atopic 
dermatitis. This latest approval represents an important next chapter for Dupixent, giving 
those with COPD a novel option that has demonstrated the unprecedented ability to help 
patients experience fewer exacerbations, while also helping them breathe better and improve 
quality of life in phase 3 studies.” 
 
The FDA evaluated Dupixent under Priority Review, which is reserved for medicines that 
represent potentially significant improvements in efficacy or safety in treating serious 
conditions. In July 2024, Sanofi and Regeneron announced that the European Medicines 
Agency approved Dupixent as an add-on maintenance treatment for adults with 
uncontrolled COPD characterized by raised blood eosinophils. Submissions are currently 
under review with other regulatory authorities around the world, including in Japan. 
 
About COPD 
COPD is a respiratory disease that damages the lungs and causes progressive lung function 
decline and is the fourth leading cause of death worldwide. Symptoms include persistent 
cough, excessive mucus production and shortness of breath that may impair the ability to 
perform routine daily activities, which may lead to sleep disturbances, anxiety, and 
depression. COPD is also associated with a significant health and economic burden due to 
recurrent acute exacerbations that require systemic corticosteroid medicine and/or 
antibiotics. Smoking and exposure to noxious particles are key risk factors for COPD, but 
even individuals who quit smoking can still have progressive lung disease.  
 
About half of COPD patients continue to experience exacerbations despite being on triple 
inhaled therapy. In the US, approximately 300,000 people live with inadequately controlled 
COPD and an eosinophilic phenotype. Patients with an eosinophilic phenotype contribute to 
an ~30% increase in exacerbations and an increased risk of COPD-related re-
hospitalizations within a year. 
 


3/6 
 
 
 
 
 
About the Dupixent COPD phase 3 study program 
BOREAS and NOTUS were replicate, randomized, phase 3, double-blind, placebo-controlled 
studies that evaluated the efficacy and safety of Dupixent in adults who were current or 
former smokers with moderate-to-severe COPD with an eosinophilic phenotype, as defined 
by blood eosinophils ≥300 cells per µL. The studies included adults with COPD across a 
broad range of clinical presentations, including those with chronic bronchitis and 
emphysema. The studies enrolled 1,874 patients who were aged 40 to 80 years in BOREAS 
and 40 to 85 years in NOTUS. 
 
During the 52-week treatment period, patients in BOREAS and NOTUS received Dupixent or 
placebo every two weeks added to a maximal standard-of-care inhaled triple therapy of ICS, 
LABA and LAMA. Double maintenance therapy, which included LABA and LAMA, was allowed 
if ICS was not appropriate. 
 
The primary endpoint for BOREAS and NOTUS evaluated the annualized rate of acute 
moderate or severe COPD exacerbations. Key secondary endpoints included change from 
baseline in lung function (assessed by pre-bronchodilator forced expiratory volume [FEV1]) 
at 12 and 52 weeks, change from baseline at 52 weeks in SGRQ total score compared to 
placebo, and safety. 
 
The results of both BOREAS and NOTUS were separately published in The New England 
Journal of Medicine. 
 
About Sanofi and Regeneron’s COPD Clinical Research Program 
Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by 
examining the role different types of inflammation play in the disease progression through 
Dupixent, a first-in-class biologic, and the investigation of itepekimab. 
 
Dupixent inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways 
and the program focuses on a specific population of people with evidence of type 2 
inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits 
interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD. 
 
Itepekimab is currently under clinical investigation for COPD in two phase 3 studies and its 
safety and efficacy have not been evaluated by any regulatory authority. 
 
About Dupixent 
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and 
IL13 pathways and is not an immunosuppressant. The Dupixent development program has 
shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, 
establishing that IL4 and IL13 are two of the key and central drivers of type 2 inflammation 
that play a major role in multiple related and often co-morbid diseases. 
 
Sanofi and Regeneron are committed to helping patients in the US who are prescribed 
Dupixent gain access to the medicine and receive the support they may need with the 
DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-
387-4936) or visit www.DUPIXENT.com. 
 
Dupixent has received regulatory approvals in more than 60 countries in one or more 
indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis 
with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, 


4/6 
 
 
 
 
 
and COPD in different age populations. More than 1,000,000 patients are being treated with 
Dupixent globally. 
 
Dupilumab Development Program 
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration 
agreement. To date, dupilumab has been studied across more than 60 clinical studies 
involving more than 10,000 patients with various chronic diseases driven in part by type 2 
inflammation. 
 
In addition to the currently approved indications, Sanofi and Regeneron are studying 
dupilumab in a broad range of diseases driven in part by type 2 inflammation or other 
allergic processes in phase 3 studies, including chronic pruritus of unknown origin and 
bullous pemphigoid. These potential uses of dupilumab are currently under clinical 
investigation, and the safety and efficacy in these conditions have not been fully evaluated 
by any regulatory authority. 
 
About Regeneron 
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and 
commercializes life-transforming medicines for people with serious diseases. Founded and 
led by physician-scientists, our unique ability to repeatedly and consistently translate 
science into medicine has led to numerous approved treatments and product candidates in 
development, most of which were homegrown in our laboratories. Our medicines and 
pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, 
cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic 
conditions, infectious diseases, and rare diseases. 
 
Regeneron pushes the boundaries of scientific discovery and accelerates drug 
development using our proprietary technologies, such as VelociSuite®, which produces 
optimized fully human antibodies and new classes of bispecific antibodies. We are shaping 
the next frontier of medicine with data-powered insights from the Regeneron Genetics 
Center® and pioneering genetic medicine platforms, enabling us to identify innovative 
targets and complementary approaches to potentially treat or cure diseases. 
 
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, 
Instagram, Facebook or X. 
 
About Sanofi  
We are an innovative global healthcare company, driven by one purpose: we chase the 
miracles of science to improve people’s lives. Our team, across the world, is dedicated to 
transforming the practice of medicine by working to turn the impossible into the possible. 
We provide potentially life-changing treatment options and life-saving vaccine protection to 
millions of people globally, while putting sustainability and social responsibility at the center 
of our ambitions.  
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 
 
Media Relations 
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com 
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com  
Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com  
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com 
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com 
 
Investor Relations 


5/6 
 
 
 
 
 
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com  
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com 
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com 
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com  
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com 
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com 
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com 
 
Regeneron Media Relations 
Hannah Kwagh | +1 914 847 6314| hannah.kwagh@regeneron.com 
 
Regeneron Investor Relations 
Vesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com 
 
 
Sanofi Forward-Looking Statements 
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. 
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding 
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements 
are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. 
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors 
are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are 
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially 
from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties 
include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the 
availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent 
in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post 
marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and 
any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact 
that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the 
financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties 
also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those 
listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-
F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to 
update or revise any forward-looking information or statements. 
 
All trademarks mentioned in this press release are the property of the Sanofi group apart from VelociSuite and Regeneron Genetics 
Center.  
 
Regeneron Forward-Looking Statements and Use of Digital Media 
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future 
performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially 
from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” 
variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-
looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among 
others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by 
Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by 
Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs 
now underway or planned, including without limitation Dupixent® (dupilumab) as an add-on maintenance treatment of adults with 
inadequately controlled chronic obstructive pulmonary disease (“COPD”) and an eosinophilic phenotype; uncertainty of the utilization, 
market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies 
(whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in 
this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products (such as Dupixent) and 
Regeneron’s Product Candidates (such as itepekimab); the likelihood, timing, and scope of possible regulatory approval and 
commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as Dupixent for the 
treatment of COPD in Japan and other jurisdictions as well as Dupixent for the treatment of chronic pruritus of unknown origin, bullous 
pemphigoid, and other potential indications; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as 
applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s 
Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product 
candidates; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product 
Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regeneron’s 
Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental 
authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and 
Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical 
programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s 
Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, 
pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement 
determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates 
that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which 
the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be 


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replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory 
approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of 
its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any 
license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated 
companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the 
COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future 
litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® 
(aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its 
operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office 
for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the 
foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of 
these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its 
Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-
looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any 
forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any 
forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, 
future events, or otherwise. 
 
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, 
including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted 
and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page 
(https://www.linkedin.com/company/regeneron-pharmaceuticals).