# LongBench v2 / 66fa7f1dbb02136c067c6e6b

task_id: 5f505725-3951-51c4-8878-43d844b8cb1c
task_key: train--66fa7f1dbb02136c067c6e6b
task_revision_id: 3

{"choice_A":"①④⑤⑥","choice_B":"①②③⑥","choice_C":"②③⑤⑥","choice_D":"②④⑤⑥","context":"1/6 \n1/6 \n \n \n \n \n \n \n \nPress Release \n \n \nDupixent approved in the EU as the first-ever targeted \ntherapy for patients with COPD  \n \n* \nFirst-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood \neosinophils based on two landmark phase 3 studies showing Dupixent significantly \nreduced exacerbations, improved lung function and also improved health-related \nquality of life \n* \nDupixent is the first new treatment approach for COPD in more than a decade and a \nnew option for approximately 220,000 adults in the EU  \n* \nApproval represents the sixth approved indication for Dupixent in the EU and seventh \napproved indication globally \n \nParis and Tarrytown, NY, July 3, 2024. The European Medicines Agency (EMA) has \napproved Dupixent (dupilumab) as an add-on maintenance treatment for adults with \nuncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood \neosinophils. Specifically, the approval covers patients already on a combination of an inhaled \ncorticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic \nantagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. The \nEMA is the first regulatory authority in the world to approve Dupixent for COPD patients. \nAdditional submissions are under review with other regulatory authorities around the world, \nincluding in the US, China, and Japan. \n \nTonya Winders  \nPresident & CEO of Global Allergy & Airways Patient Platform  \n“As a progressive and devastating disease, COPD leads to suffering from breathlessness that \nlimits a person’s ability to conduct everyday activities such as walking up the stairs or to the \nmailbox. Many patients feel marginalized and isolated because of the physical and mental \ntoll of the disease. After more than a decade of limited treatment advancements for those \nliving with uncontrolled COPD, we are now in a new era of disease management for patients \nand caregivers, and we welcome the addition of innovative, new treatments such as Dupixent \nto help manage this progressive and irreversible disease.”  \n \nPaul Hudson \nChief Executive Officer at Sanofi  \n“Patients with uncontrolled COPD have been waiting for a new treatment approach for many \nyears, so we are thrilled to bring to market the first biologic to target an underlying cause of \nthis devastating disease to reduce COPD exacerbations and improve lung function. With \ntoday’s approval of Dupixent, we can change the treatment landscape for the more than \n200,000 patients throughout the EU living with uncontrolled COPD with raised blood \neosinophils. We look forward to working with other regulators around the world as quickly \nas possible to bring this novel treatment approach to patients in more countries.”  \n \nThe approval is based on results from the landmark phase 3 BOREAS and NOTUS  studies, \nwhich were separately published in The New England Journal of Medicine and evaluated the \nefficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 \n\n\n2/6 \n2/6 \n \n \n \n \n \n \n \ninflammation (i.e., blood eosinophils ≥300 cells per µL). All patients were on background \nmaximal standard-of-care inhaled therapy (with nearly all on triple therapy). In terms of \nefficacy, Dupixent patients in BOREAS (n=468) and NOTUS (n=470) experienced the \nfollowing, respectively, compared to placebo (BOREAS n=471; NOTUS n=465): \n• \n30% and 34% reduction in the annualized rate of moderate or severe COPD \nexacerbations over 52 weeks, the primary endpoint.  \n• \nImprovements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and \n139 mL at 12 weeks compared to 77 mL and 57 mL. These improvements were \nobserved as early as week 2 and 4 and were sustained at 52 weeks in both studies.  \n• \nImprovements in health-related quality of life (statistically significant in BOREAS and \nnominally significant in NOTUS), as assessed by the St. George’s Respiratory \nQuestionnaire. \n \nReductions in exacerbations and improvements in lung function for Dupixent versus placebo \nwere also observed in patients with higher baseline fractional exhaled nitric oxide (≥20ppb) \n- an airway biomarker of inflammation – and across all pre-defined subgroups including \nsmoking status, baseline lung function, and history of exacerbations. \n \nSafety results in both studies were generally consistent with the known safety profile of \nDupixent in its approved indications. The most common side effects across indications include \ninjection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and \neosinophilia. Adverse events more commonly observed with Dupixent (≥5%) compared to \nplacebo in either COPD study were back pain, COVID-19, diarrhea, headache and \nnasopharyngitis. Additional adverse reactions of injection site bruising, injection site \ninduration, injection site rash and injection site dermatitis were reported in the COPD studies. \n \nGeorge D. Yancopoulos, M.D., Ph.D. \nBoard Co-Chair, President and Chief Scientific Officer at Regeneron \n“The approval of Dupixent for COPD is a long-awaited turning point for those who struggle \nto breathe even through the simplest of tasks, while also facing the risk of hospitalization, \nirreversible health decline and feelings of hopelessness. With this approval, we are proud that \nDupixent has the potential to redefine the treatment landscape in yet another disease, as a \nfirst-in-class therapy demonstrating unprecedented improvements on exacerbations and \nlung function, as well as improving health-related quality of life across two large phase 3 \ntrials.” \n \nAbout COPD \nCOPD is a respiratory disease that damages the lungs and causes progressive lung function \ndecline and is the fourth leading cause of death worldwide. Symptoms include persistent \ncough, excessive mucus production and shortness of breath that may impair the ability to \nperform routine daily activities, which may lead to sleep disturbances, anxiety, and \ndepression. COPD is also associated with a significant health and economic burden due to \nrecurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to \nhospitalization. Smoking and exposure to noxious particles are key risk factors for COPD, but \neven individuals who quit smoking can still develop or continue having the disease. There \nhave been no new treatment approaches approved for more than a decade. \n \nAbout the Dupixent COPD phase 3 study program \nBOREAS and NOTUS were replicate, randomized, phase 3, double-blind, placebo-controlled \nstudies that evaluated the efficacy and safety of Dupixent in adults who were current or former \n\n\n3/6 \n3/6 \n \n \n \n \n \n \n \nsmokers with moderate-to-severe COPD with evidence of type 2 inflammation, as measured \nby blood eosinophils ≥300 cells per µL. The studies enrolled 1,874 patients who were aged \n40 to 80 years in BOREAS and 40 to 85 years in NOTUS.  \n \nDuring the 52-week treatment period, patients in BOREAS and NOTUS received Dupixent or \nplacebo every two weeks added to a maximal standard-of-care inhaled triple therapy of ICS, \nLABA and LAMA. Double maintenance therapy, which included LABA and LAMA, was allowed \nif ICS was not appropriate. \n \nThe primary endpoint for BOREAS and NOTUS evaluated the annualized rate of moderate or \nsevere COPD exacerbations. Moderate exacerbations were defined as those requiring systemic \nsteroids and/or antibiotics. Severe exacerbations were defined as those requiring \nhospitalization; requiring more than a day of observation in an emergency department or \nurgent care facility; or resulting in death. Key secondary endpoints included change from \nbaseline in lung function (assessed by pre-bronchodilator forced expiratory volume [FEV1]) at \n12 and 52 weeks, change from baseline at 52 weeks in SGRQ total score compared to placebo, \nand safety. \n \nAbout Sanofi and Regeneron’s COPD clinical research program \nSanofi and Regeneron are motivated to transform the treatment paradigm of COPD by \nexamining the role different types of inflammation play in the disease progression through \nthe investigation of two potentially first-in-class biologics, Dupixent and itepekimab. \n \nDupixent inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways \nand the program focuses on a specific population of people with evidence of type 2 \ninflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits \ninterleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD. \n \nItepekimab is currently under clinical investigation in two phase 3 studies, and its safety and \nefficacy have not been evaluated by any regulatory authority. \n \nAbout Dupixent \nDupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 \n(IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent \ndevelopment program has shown significant clinical benefit and a decrease in type 2 \ninflammation in phase 3 studies, establishing that IL4 and IL13 are key and central drivers of \nthe type 2 inflammation that plays a major role in multiple related and often co-morbid \ndiseases. \n \nDupixent has received regulatory approvals in more than 60 countries in one or more \nindications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis \nwith nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous \nurticaria, and COPD in different age populations. More than 900,000 patients are being treated \nwith Dupixent globally. \n \nDupilumab Development Program \nDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration \nagreement. To date, dupilumab has been studied across more than 60 clinical studies \ninvolving more than 10,000 patients with various chronic diseases driven in part by type 2 \ninflammation. \n\n\n4/6 \n4/6 \n \n \n \n \n \n \n \n \nIn addition to the currently approved indications, Sanofi and Regeneron are studying \ndupilumab in a broad range of diseases driven by type 2 inflammation or other allergic \nprocesses in phase 3 studies, including chronic pruritus of unknown origin and bullous \npemphigoid. These potential uses of dupilumab are currently under clinical investigation, and \nthe safety and efficacy in these conditions have not been fully evaluated by any regulatory \nauthority. \n \nAbout Regeneron \nRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and \ncommercializes life-transforming medicines for people with serious diseases. Founded and led \nby physician-scientists, our unique ability to repeatedly and consistently translate science into \nmedicine has led to numerous approved treatments and product candidates in development, \nmost of which were homegrown in our laboratories. Our medicines and pipeline are designed \nto help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular \nand metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, \nand rare diseases. \n \nRegeneron pushes \nthe \nboundaries \nof \nscientific \ndiscovery \nand accelerates \ndrug \ndevelopment using our proprietary technologies, such as VelociSuite®, which produces \noptimized fully human antibodies and new classes of bispecific antibodies. We are shaping the \nnext frontier of medicine with data-powered insights from the Regeneron Genetics \nCenter® and pioneering genetic medicine platforms, enabling us to identify innovative targets \nand complementary approaches to potentially treat or cure diseases. \n \nFor more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, \nInstagram, Facebook or X. \n \nAbout Sanofi  \nWe are an innovative global healthcare company, driven by one purpose: we chase the \nmiracles of science to improve people’s lives. Our team, across the world, is dedicated to \ntransforming the practice of medicine by working to turn the impossible into the possible. We \nprovide potentially life-changing treatment options and life-saving vaccine protection to \nmillions of people globally, while putting sustainability and social responsibility at the center \nof our ambitions. \n \nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY \n \nSanofi Media Relations \nSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.com \nVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com \nTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com \n \nSanofi Investor Relations \nThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com \nAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com \nArnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com \nFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com \nKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.com \nNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com \nTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com \nThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com \n\n\n5/6 \n5/6 \n \n \n \n \n \n \n \n \nRegeneron Media Relations \nHannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com \n  \nRegeneron Investor Relations \nVesna Tosic | + 914-847-5443 | vesna.tosic@regeneron.com \n \n \nSanofi Forward-Looking Statements \nThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. \nForward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding \nthe marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements \nare generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. \nAlthough Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors \nare cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are \ndifficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially \nfrom those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties \ninclude among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the \navailability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent \nin research and development, including future clinical data and analysis of existing clinical data relating to the product, including post \nmarketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and \nany related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact \nthat pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the \nfinancial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties \nalso include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those \nlisted under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-\nF for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to \nupdate or revise any forward-looking information or statements.  \n  \nAll trademarks mentioned in this press release are protected. \n \n \nRegeneron Forward-Looking Statements and Use of Digital Media  \nThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future \nperformance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially \nfrom these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” \nvariations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-\nlooking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among \nothers, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by \nRegeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by \nRegeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs \nnow underway or planned, including without limitation Dupixent® (dupilumab) as an add-on maintenance treatment for adults with \nuncontrolled chronic obstructive pulmonary disease (“COPD”) characterized by raised blood eosinophils on a combination of an inhaled \ncorticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a \nLABA and a LAMA if ICS is not appropriate; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s \nProducts and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether \nmandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential \nregulatory approval of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates (such as itepekimab); the \nlikelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new \nindications for Regeneron’s Products, such as Dupixent for the treatment of COPD in the United States, China, and other jurisdictions \nas well as Dupixent for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, and other potential indications; the \nability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, \nfinishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the \nability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the \nadministration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates (such as itepekimab) in patients, \nincluding serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates \nin clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s \nability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory \nobligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to \npatient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer \nhealthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government \nprograms such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and \nprocedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, \nRegeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development \nprograms conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement \nof product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of \ndeveloping, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes \nto the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, \nincluding Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or \nterminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's \n\n\n6/6 \n6/6 \n \n \n \n \n \n \n \nbusiness; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including \nwithout limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other litigation and \nother proceedings and government investigations relating to the Company and/or its operations (including the pending civil \nproceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the \nultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, \nprospects, operating results, and financial condition. A more complete description of these and other material risks can be found in \nRegeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, \n2023 and its Form 10-Q for the quarterly period ended March 31, 2024. Any forward-looking statements are made based on \nmanagement’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by \nRegeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including \nwithout limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.  \nRegeneron uses its media and investor relations website and social media outlets to publish important information about the \nCompany, including information that may be deemed material to investors. Financial and other information about Regeneron is \nroutinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its \nLinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). \n \n\n\n1/4 \n \n \n \nPress Release \n \n \nSarclisa approved in the US as the first anti-CD38 therapy \nin combination with standard-of-care treatment for adult \npatients with newly diagnosed multiple myeloma not \neligible for transplant \n  \n \n• \nApproval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa \nin combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly \nimproved progression-free survival (PFS), compared to standard-of-care in newly \ndiagnosed adult patients not eligible for autologous stem cell transplant (ASCT) \n• \nThird indication for Sarclisa, evaluated under FDA Priority Review, underscores Sanofi’s \ncommitment to helping close a critical care gap in multiple myeloma (MM)   \n \nPARIS, September 21, 2024. The US Food and Drug Administration (FDA) has approved \nSarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) \nas a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) \nwho are not eligible for autologous stem cell transplant (ASCT). Sarclisa is the first anti-CD38 \ntherapy in combination with standard-of-care VRd to significantly reduce disease progression or \ndeath (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant. \n \nThomas Martin M.D. \nHelen Diller Family Comprehensive Cancer Center Clinical Professor of Medicine at the \nUniversity of California San Francisco \n“Multiple myeloma is most frequently diagnosed in patients 65 years and older, yet the options \nfor treatment in this population are limited due to a combination of age, frailty, and co-\nmorbidities. This has resulted in a longstanding need for new treatment options that can \npotentially improve the standard-of-care. The significant clinical benefit and improvements in \nprogression-free survival demonstrated by the IMROZ regimen of isatuximab plus VRd versus \nVRd alone make today’s approval an important moment for this vulnerable patient population \nand the larger multiple myeloma community.”  \n \nThis decision marks the third approved indication for Sarclisa in the US and the first approved \nindication in newly diagnosed patients. The FDA evaluated Sarclisa for this indication under \nPriority Review, which is reserved for medicines that represent potentially significant \nimprovements in efficacy or safety in treating serious conditions. Sarclisa is also currently \napproved in more than 50 countries across two indications for the treatment of people with \nrelapsed or refractory disease.\n \nBrian Foard \nExecutive Vice President, Head of Specialty Care, Sanofi \n“Since first launching in 2020, we have made significant progress towards our ambition of \nestablishing Sarclisa as a best-in-class therapy. The FDA’s decision marks another momentous \nmilestone toward our goal and expands the reach of this potentially transformative therapy to a \nlarger population. With today’s approval, doctors now have an important new option at their \ndisposal that’s been shown to slow disease progression for longer compared to the current \nstandard-of-care for adults living with newly diagnosed multiple myeloma who are not eligible \nfor transplant in the US.” \n \nResults from the IMROZ phase 3 study supporting Sarclisa in NDMM not eligible for ASCT \n \nThe FDA approval is based on data from the IMROZ phase 3 study recently presented at the \nAmerican Society of Clinical Oncology (ASCO) 2024 annual meeting and published in The New \nEngland Journal of Medicine. IMROZ is the first global phase 3 study of an anti-CD38 monoclonal \n\n\n2/4 \n \nantibody in combination with standard-of-care VRd to significantly improve PFS versus VRd \nalone. \n \nIn the IMROZ study, Sarclisa-VRd followed by Sarclisa-Rd met the primary endpoint of PFS, \nsignificantly reducing the risk of recurrence or death by 40%, compared to VRd followed by Rd, \nin patients with NDMM not eligible for ASCT (HR 0.60; 95% CI: 0.44 to 0.81, p=0.0009). At a \nmedian follow-up of 59.7 months, the median PFS with the Sarclisa-VRd combination was not \nreached versus 54.3 months with VRd. The estimated PFS-rate at 60 months was 63.2% for \npatients treated with Sarclisa-VRd versus 45.2% for VRd.  \n \nSarclisa-VRd also met several secondary endpoints which demonstrated deep responses in this \npatient population:  \n• \nApproximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a \ncomplete response (CR) or better compared to 64.1% of patients taking VRd (OR 1.7; \n95% CI: 1.097-2.5; p=0.0160). \n• \nMore than half (55.5%) of patients treated with Sarclisa-VRd achieved MRD negative CR \ncompared to 40.9% of patients taking VRd (OR 1.8; 95% CI: 1.229-2.646; p=0.0026). \n \nThe safety and tolerability of Sarclisa observed in this study was consistent with the established \nsafety profile of Sarclisa and VRd with no new safety signals observed. The most common \nadverse reactions (≥20%) were upper respiratory tract infections, diarrhea, fatigue, peripheral \nsensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral \nedema, rash, infusion-related reaction, insomnia, and COVID-19. The most common hematologic \nlaboratory abnormalities (≥80%) were decreased hemoglobin, decreased leukocytes, decreased \nlymphocytes, decreased platelets, and decreased neutrophils. Serious adverse reactions \noccurred in 71% of patients receiving Sarclisa combination therapy. The most frequent serious \nadverse reaction occurring in more than 5% of patients was pneumonia (30%). Permanent \ndiscontinuation of treatment due to an adverse reaction occurred in 22.8% of patients treated \nwith Sarclisa combination therapy, compared to 26% in the comparator arm.   \n \nAdvancing Sarclisa in multiple myeloma \n \nSanofi continues to advance Sarclisa as part of a patient-centric clinical development program, \nwhich includes several phase 2 and phase 3 studies across the MM treatment continuum \nspanning six potential indications. In addition, the company is evaluating a subcutaneous \nadministration method for Sarclisa in clinical studies. The safety and efficacy of Sarclisa has not \nbeen evaluated by any regulatory authority outside of its approved indications and methods of \ndelivery.  \n \nIn September, isatuximab-irfc (Sarclisa) was also added to the National Comprehensive Cancer \nNetwork (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for MM non-\ntransplant candidates as an NCCN Category 1 Preferred option in combination with VRd for \npatients <80 years old who are not frail. Category 1 is based upon high-level evidence, there is \nuniform NCCN consensus that the intervention is appropriate. Preferred intervention are \ninterventions that are based on superior efficacy, safety, and evidence; and, when appropriate, \naffordability. \n \n*NCCN makes no warranties of any kind whatsoever regarding their content, use or application \nand disclaims any responsibility for their application or use in any way. \n \nAbout Sarclisa \nSarclisa (isatuximab) is a monoclonal antibody that binds to a specific epitope on the CD38 \nreceptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple \nmechanisms \nof \naction \nincluding \nprogrammed \ntumor \ncell \ndeath \n(apoptosis) \nand \nimmunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, \nmaking it a target for antibody-based therapeutics such as Sarclisa. \n  \nBased on the ICARIA-MM phase 3 study, Sarclisa is approved in more than 50 countries, \nincluding the US and the EU, in combination with pomalidomide and dexamethasone for the \n\n\n3/4 \n \ntreatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, \nincluding lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based \non the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with \ncarfilzomib and dexamethasone, including in the US for the treatment of patients with RRMM \nwho have received 1–3 prior lines of therapy and in the EU for patients with MM who have \nreceived at least one prior therapy. In the US, the non-proprietary name for Sarclisa is \nisatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of \nbiological products guidance for industry issued by the US Food and Drug Administration. \n  \nSarclisa continues to be evaluated in multiple ongoing phase 3 clinical studies in combination \nwith current standard treatments across the MM treatment continuum. It is also under \ninvestigation for the treatment of other hematologic malignancies, and its safety and efficacy \nhave not been evaluated by any regulatory authority outside of its approved indication. \n \nSanofi is committed to pursuing the advancement of Sarclisa through several investigational \nstudies across the MM treatment continuum. Various patient-centric clinical development \nprograms aim to bring Sarclisa to more patients, intercept the disease earlier in the treatment \njourney, explore potential new combinations and assess subcutaneous administration via a \nproprietary on body device system. The safety and efficacy of Sarclisa has not been evaluated \nby any regulatory authority outside of its approved indications and methods of delivery. \n  \nIn striving to become the number one immunoscience company globally, Sanofi remains \ncommitted to advancing oncology innovation. Through focused strategic decisions the company \nhas reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive \nprogress. Efforts are centered on difficult-to-treat cancers such as select hematologic \nmalignancies, and solid tumors with critical unmet needs, including multiple myeloma, acute \nmyeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers. \n \nFor more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov. \n \nAbout multiple myeloma \nMM is the second most common hematologic malignancy1, affecting more than 130,000 \npatients in the US; approximately 32,000 Americans are diagnosed with MM each year.2 \nDespite available treatments, MM remains an incurable malignancy with an estimated 52% \nfive-year survival rate for newly diagnosed patients.3 According to physician-based surveys, \nthe majority of NDMM patients are not considered eligible for transplant, creating a need for \nnew frontline therapeutic options, particularly due to high attrition rates in subsequent lines of \ntherapy. \n \n \nAbout Sanofi  \nWe are an innovative global healthcare company, driven by one purpose: we chase the miracles \nof science to improve people’s lives. Our team, across the world, is dedicated to transforming \nthe practice of medicine by working to turn the impossible into the possible. We provide \npotentially life-changing treatment options and life-saving vaccine protection to millions of \npeople globally, while putting sustainability and social responsibility at the center of our \nambitions. \n \nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY \n \nMedia Relations \nSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com  \nNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com  \nVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com \nTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com \n \nInvestor Relations \nThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com  \nAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com \nArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com \n\n\n4/4 \n \nFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com  \nKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.com \nNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com \nTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  \nThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com \n \n \nSanofi Forward-Looking Statements \nThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, \nas amended. Forward-looking statements are statements that are not historical facts. These statements include \nprojections and estimates regarding the marketing and other potential of the product, or regarding potential future \nrevenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, \n“believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the \nexpectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking \ninformation and statements are subject to various risks and uncertainties, many of which are difficult to predict and \ngenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those \nexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties \ninclude among other things, unexpected regulatory actions or delays, or government regulation generally, that could \naffect the availability or commercial potential of the product, the fact that product may not be commercially successful, \nthe uncertainties inherent in research and development, including future clinical data and analysis of existing clinical \ndata relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition \nin general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such \nlitigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have \non us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, \nas well as on our employees and on the global economy as a whole. The risks and uncertainties also include the \nuncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed \nunder “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on \nForm 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake \nany obligation to update or revise any forward-looking information or statements. \n \nAll trademarks mentioned in this press release are the property of the Sanofi group. \n \n1 Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. \ndoi:10.1053/j/seminoncol.2016.11.004. \n2 National Cancer Institute. Myeloma Cancer Stat Facts. Available at: \nwww.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on December 12, 2019. \n3 Fonseca, R., Usmani, S.Z., Mehra, M. et al. Frontline treatment patterns and attrition rates by subsequent lines of \ntherapy in patients with newly diagnosed multiple myeloma. BMC Cancer. 2020: 20(1087). \nhttps://doi.org/10.1186/s12885-020-07503-y. \n\n\n1/4 \n \n \n \n \n \nPress Release \n \nTolebrutinib demonstrated a 31% delay in time to onset of \nconfirmed disability progression in non-relapsing \nsecondary progressive multiple sclerosis phase 3 study \n \n• \nData presented at ECTRIMS show that tolebrutinib, a brain-penetrant BTK inhibitor, \naddresses disability accumulation that occurs independently from relapse activity \n• \nGlobal regulatory submissions will begin in H2 2024 \n \nParis, September 20, 2024. Positive results from the HERCULES phase 3 study in people \nwith non-relapsing secondary progressive multiple sclerosis (nrSPMS) demonstrated that \ntolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by \n31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026). Further analysis of \nsecondary endpoints demonstrated that the number of participants who experienced confirmed \ndisability improvement increased by nearly two-fold, 10% with tolebrutinib compared to 5% \nwith placebo (HR 1.88; 95% CI 1.10 to 3.21; nominal p=0.021). These results were presented \ntoday as a late-breaking presentation at the European Committee for Treatment and Research \nin Multiple Sclerosis (ECTRIMS) 2024 conference in Copenhagen, Denmark. \n \nRobert Fox, MD \nVice Chair of Research at Cleveland Clinic’s Neurological Institute, Cleveland, Ohio and \nChair of the HERCULES Global Steering Committee \n“Secondary progressive multiple sclerosis is characterized by insidious worsening of disability over \ntime, independent of relapses, and represents a critical unmet need because we don’t have effective \ntreatments. The results of HERCULES show clearly that tolebrutinib delayed disability progression in \npeople with nrSPMS – and some people even improved disability – by uniquely targeting the \nbiological processes driving disease progression in the brain.” Dr. Fox is a paid advisor to Sanofi for \nthe HERCULES trial. \n \nBased on preliminary analysis of the HERCULES study, there was a slight increase in \ntolebrutinib-treated patients of some adverse events. Liver enzyme elevations (>3xULN) were \nobserved in 4.1% of participants receiving tolebrutinib compared with 1.6% in the placebo \ngroup, a side effect also reported with other BTK inhibitors in MS. A small (0.5%) proportion of \nparticipants in the tolebrutinib group experienced peak ALT increases of >20xULN, all occurring \nwithin the first 90 days of treatment. All but one case of liver enzyme elevations resolved \nwithout further medical intervention. Prior to the implementation of the revised study protocol \nwith more stringent monitoring, one participant in the tolebrutinib arm received a liver \ntransplant and died due to post-operative complications. To date, the implementation of more \nfrequent monitoring has mitigated such serious liver sequelae. Other deaths in the trial were \nassessed as unrelated to treatment by investigator; deaths were even across the placebo and \ntolebrutinib arms at 0.3%.  \n \nAdverse events (≥10%*)  \ntolebrutinib \nN=752 (%) \nplacebo \nN=375 (%) \nCOVID-19 infections \n192 (25.5%) \n85 (22.7%) \nUrinary tract infections \n85 (11.3%) \n49 (13.1%) \n*For participants receiving tolebrutinib \n \nHouman Ashrafian, MD, PhD \nHead of Research & Development, Sanofi \n“With no treatment options currently available for the broad population of patients with secondary \nprogressive multiple sclerosis, tolebrutinib has demonstrated its ability to delay disability by targeting \nunderlying drivers of the disease. We look forward to discussing these results with healthcare \n\n\n2/4 \n \n \n \nauthorities and are eager to see the results of tolebrutinib in primary progressive MS when they \nbecome available next year. We extend our deepest appreciation to the study participants, their \nfamilies, and the healthcare professionals involved in these trials.” \n \nThe GEMINI 1 and 2 phase 3 study results of tolebrutinib compared to Aubagio (teriflunomide), \na standard-of-care treatment, in participants with relapsing multiple sclerosis (RMS) were also \npresented today as a late-breaking presentation at ECTRIMS. Both studies did not meet their \nprimary endpoints of statistically significant improvement in annualized relapse rates (ARR) \ncompared to Aubagio. However, in the key secondary endpoint, a pooled analysis of data from \nGEMINI 1 and 2, tolebrutinib delayed the time to onset of 6-month confirmed disability \nworsening (CDW) by 29% (HR 0.71; 95% CI: 0.53-0.95; nominal p=0.023). The results of the \n29% delay in CDW endpoint in participants with RMS are in line with the 31% delay in CDP \nobserved in participants with nrSPMS. The significant impact of tolebrutinib on disability \naccumulation versus Aubagio, in the absence of a statistically superior impact on relapses, \nsuggests that tolebrutinib may address smoldering neuroinflammation, which manifests as \nprogression independent of relapses. \nFurthermore, results showed historically low ARR in the Aubagio arm in both GEMINI 1 and 2, \nand no difference was observed between Aubagio and tolebrutinib in a pooled analysis. These \nrelapse rates amount to approximately 1 relapse every 8 years.  \n \n \ntolebrutinib ARR \nAubagio ARR \nGEMINI 1  \n(adjusted rate ratio 1.06; 95% CI: 0.80 to 1.39; p=0.67) \n0.13 \n0.12 \nGEMINI 2  \n(adjusted rate ratio 1.00; 95% CI: 0.75 to 1.32; p=0.98) \n0.11 \n0.11 \nPooled analysis \n(adjusted rate ratio 1.03; 95% CI: 0.84 to 1.25; p=0.80) \n0.12 \n0.12 \n \nIn preliminary analysis of the GEMINI 1 and 2 pooled safety data, adverse events observed \nbetween the tolebrutinib and Aubagio arms were generally balanced. Liver enzyme elevations \n(>3x ULN) were observed in 5.6% of participants receiving tolebrutinib compared with 6.3% of \nparticipants receiving Aubagio, a side effect reported with other BTK inhibitors in MS and \nresolved without further medical intervention. A small (0.5%) proportion of participants in the \ntolebrutinib group experienced peak ALT increases of >20xULN, all occurring within the first 90 \ndays of treatment. Deaths were balanced across the Aubagio and tolebrutinib arms, at 0.2% \nand 0.1% respectively, and were assessed as unrelated to treatment by investigator.  \n \nAdverse events (≥10%*) \nTolebrutinib  \nN=933 (%) \nAubagio \nN=939 (%) \nCOVID-19 infections \n225 (24.1%) \n252 (26.8%) \nNasopharyngitis \n119 (12.8%) \n105 (11.2%) \nHeadache \n117 (12.5%) \n98 (10.4%) \n*For participants receiving tolebrutinib \n \nStudy results will form the basis for future discussions with global regulatory authorities with \nsubmissions starting in H2 2024. Tolebrutinib is currently under clinical investigation, and its \nsafety and efficacy have not been evaluated by any regulatory authority.  \n \nThe PERSEUS phase 3 study in primary progressive MS is currently ongoing with study results \nanticipated in H2 2025. \n \nAbout Multiple Sclerosis \nMultiple sclerosis is a chronic, immune-mediated, neurodegenerative disease that results in \naccumulation of irreversible disabilities over time. The physical and cognitive disability \nimpairments translate into gradual deterioration of health status and lower quality of life, \nimpacting patients’ care and life expectancy. Disability accumulation remains the significant \nunmet medical need in MS. To date, the primary target of current therapies has been \nperipheral B and T cells, while innate immunity, which is believed to drive disability \naccumulation, remains largely unaddressed by current therapies. Currently approved, or \n\n\n3/4 \n \n \n \nmedicines being tested for MS mainly target the adaptive immune system and/or do not act \ndirectly within the central nervous system (CNS) to drive clinical benefit.  \n  \nRMS refers to people with MS who experience episodes of new or worsening symptoms (known \nas relapses) followed by periods of partial or complete recovery. nrSPMS refers to people with \nMS who have stopped experiencing confirmed relapses but continue to experience \naccumulation of disability, experienced as symptoms such as fatigue, cognition impairment, \nbalance and gait impairment, loss of bowel and/or bladder function, sexual disfunction, \namongst others. \n \nAbout HERCULES \nHERCULES (NCT04411641) was a double-blind randomized phase 3 clinical study evaluating \nthe efficacy and safety of tolebrutinib in participants with nrSPMS. nrSPMS was defined at \nbaseline as having a SPMS diagnosis with an expanded disability status scale (EDSS) between \n3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of \ndisability accumulation in the previous 12 months. Participants were randomized (2:1) to \nreceive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 \nmonths. \n \nThe primary endpoint was 6-month CDP defined as the increase of ≥1.0 point from the \nbaseline EDSS score when the baseline score is ≤5.0, or the increase of ≥0.5 point when the \nbaseline EDSS score was >5.0. Secondary endpoints included 3-month change in 9 hole peg \ntest and T25-FW test, time to onset of 3-month CDP as assessed by EDSS score, total number \nof new or enlarging T2 hyperintense lesions as detected by MRI, change in cognitive function \nat the EOS compared to baseline as assessed by the Symbol Digit Modalities Test and by the \nCalifornia Verbal Learning Test as well as the safety and tolerability of tolebrutinib. \n \nAbout GEMINI 1 and 2 \nGEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier: \nNCT04410991) were double-blind randomized phase 3 clinical studies evaluating the efficacy \nand safety of tolebrutinib compared to Aubagio in participants with relapsing forms of MS. \nParticipants were randomized in both studies (1:1) to receive either tolebrutinib and placebo \ndaily or 14mg Aubagio and placebo. \n \nThe primary endpoint for both studies was the annualized relapse rate for up to approximately \n36 months defined as the number of confirmed adjudicated protocol defined relapses. \nSecondary endpoints included time to onset of CDW, confirmed over at least 6 months, defined \nas an increase of ≥1.5 points from the baseline EDSS score when the baseline score is 0, an \nincrease of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 or \nan increase of ≥0.5 point from the baseline EDSS score when the baseline score was >5.5 in \naddition to the total number of new and/or enlarging T2 hyperintense lesions as detected by \nMRI from baseline through the end of study, the total number of Gd-enhancing T1 \nhyperintense lesions as detected by MRI from baseline through the end of study and the safety \nand tolerability of tolebrutinib. \n \nAbout tolebrutinib \nTolebrutinib is an investigational, oral, brain-penetrant, and bioactive Bruton’s tyrosine kinase \n(BTK) inhibitor that achieves CSF concentrations predicted to modulate B lymphocytes and \ndisease-associated microglia. Tolebrutinib is being evaluated in phase 3 clinical studies for the \ntreatment of various forms of multiple sclerosis and its safety and efficacy have not been \nevaluated by any regulatory authority worldwide. For more information on tolebrutinib clinical \nstudies, please visit www.clinicaltrials.gov. \n \n \nAbout Sanofi  \nWe are an innovative global healthcare company, driven by one purpose: we chase the \nmiracles of science to improve people’s lives. Our team, across the world, is dedicated to \ntransforming the practice of medicine by working to turn the impossible into the possible. We \nprovide potentially life-changing treatment options and life-saving vaccine protection to \n\n\n4/4 \n \n \n \nmillions of people globally, while putting sustainability and social responsibility at the center of \nour ambitions.  \nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY \n \nMedia Relations \nSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com  \nNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com  \nVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com \nTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com \n \nInvestor Relations \nThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com  \nAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com \nArnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com \nFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com  \nKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.com \nNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com \nTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  \nThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com \n \nSanofi forward-looking statements \nThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. \nForward-looking statements are statements that are not historical facts. These statements include projections and estimates and their \nunderlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, \nevents, operations, services, product development and potential, and statements regarding future performance. Forward-looking \nstatements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar \nexpressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are \nreasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, \nmany of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to \ndiffer materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and \nuncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, \nincluding post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any \ndrug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and \nother matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if \napproved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability \nto benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated \nwith intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange \nrates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes \nthereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business \npartners, 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 \nand uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, \nincluding those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual \nreport on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any \nobligation to update or revise any forward-looking information or statements. \nAll trademarks mentioned in this press release are the property of the Sanofi group, \n \n\n\n1/3 \n \n \nPress Release \n \n \n \n \nNEJM publishes ALTUVIIIO XTEND-Kids phase 3 data \nsupporting its potential to transform the treatment \nlandscape for children with severe hemophilia A \n \n• \nALTUVIIIO provides high-sustained factor levels with once-weekly dosing in children \nunder 12 with hemophilia A  \n• \nXTEND-Kids results show highly effective bleed protection in hemophilia A with no \ninhibitor development to factor VIII  \n \nParis, July 17, 2024 – Full results from the XTEND-Kids phase 3 study published in The New \nEngland Journal of Medicine (NEJM) highlights the efficacy, safety, and pharmacokinetic profile \nof ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein]. ALTUVIIIO \n(efanesoctocog alfa), a first-in-class, high-sustained factor VIII replacement therapy, is \napproved for adults and children with hemophilia A for routine prophylaxis and on-demand \ntreatment to control bleeding episodes as well as for perioperative management (surgery).  \n \nLynn Malec, MD \nMedical Director of Comprehensive Center for Bleeding Disorders and Associate Investigator \nat The Versiti Blood Research Institute, and Associate Professor of Medicine and Pediatrics \nat The Medical College of Wisconsin  \n“Children represent a population for which it has been historically difficult to achieve effective \nbleed prevention and these published results demonstrate an important breakthrough as we \nstrive to optimize the standard of care. Achieving high-sustained factor activity with once-weekly \ndosing helps mitigate the need to make a tradeoff between the treatment burden of factor \nreplacement therapy and efficacy, which we often witness in treating severe hemophilia.” \n  \nThe pivotal XTEND-Kids study published in NEJM shows ALTUVIIIO met primary and secondary \nendpoints, which included occurrence of factor VIII inhibitors and annualized bleed rates \n(ABRs). The results show no inhibitor development to factor VIII was detected with ALTUVIIIO \n(0% [95% confidence interval (CI)] 0–5]). The median annualized bleed rate (ABR) was 0.00 \n(interquartile range [IQR]: 0.00-1.02), and the estimated mean (95% CI) ABR was 0.61 \n(0.42–0.90) in the study of 73 patients treated per protocol. In the pediatric population, \nclearance of administered factor concentrates from the blood is greater than in adults, often \nmeaning injections are needed 2-4 times per week using standard (SHL) or extended half-life \n(EHL) factor VIII products.  \n \nPrevention of all joint bleeds is critical to maintain joint health throughout life. Eighty-two \npercent of the children treated with once-weekly ALTUVIIIO had zero joint bleeds, \ndemonstrating ALTUVIIIO weekly prophylaxis has the potential to provide long-term \npreservation of joint health.  \n \nDietmar Berger, MD, PhD \nGlobal Head of Development and Chief Medical Officer at Sanofi \n“The XTEND-Kids data validate the connection between high-sustained factor activity levels and \nimproved health outcomes, including joint health. Offering a treatment option that emphasizes \neffective bleed protection in children with hemophilia can help give families increased peace of \nmind when their loved ones participate in everyday activities. The results are a testament to our \nscientific expertise and commitment to redefine the standard of care for children living with \nhemophilia through ALTUVIIIO and our broader portfolio of hemophilia therapies.”   \n\n\n2/3 \n \n \nALTUVIIIO was well-tolerated in children, and no adverse events led to treatment \ndiscontinuation. The most common treatment-emergent adverse events (>10%) were SARS-\nCoV-2 test positive, upper respiratory tract infection, and fever (pyrexia). No serious allergic \nreactions, anaphylaxis, or embolic or thrombotic events were reported.  \n \nAbout ALTUVIIIO \nALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] is a first-in-\nclass high-sustained factor VIII therapy that is designed to extend protection from bleeds with \nonce-weekly prophylactic dosing for adults and children with hemophilia A. In adults and \nadolescents, ALTUVIIIO has a 3 to 4-fold longer half-life relative to standard and extended half-\nlife factor VIII products, providing high-sustained factor activity levels within normal to near-\nnormal range, allowing for once-weekly administration. ALTUVIIIO is the first factor VIII therapy \nthat has been shown to break through the von Willebrand factor ceiling, which imposes a half-\nlife limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on the innovative Fc \nfusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend \nits time in circulation. \n \nALTUVIIIO is currently approved and marketed in the US, Taiwan, and Japan. On June 17, 2024, \nit was approved by the European Commission for the treatment and prevention of bleeds and \nperioperative prophylaxis in hemophilia A under the name ALTUVOCT. \n \nALTUVIIIO is the first factor VIII therapy to receive Breakthrough Therapy Designation by the \nUS Food and Drug Administration in May 2022, Fast Track Designation in February 2021, and \nOrphan Drug Designation in 2017. The European Commission granted orphan designation in \nJune 2019. \n \nAbout XTEND-Kids \nThe XTEND-Kids study (NCT04759131) was an open-label, non-randomized interventional study \nof once-weekly ALTUVIIIO in previously treated patients younger than 12 years of age with \nsevere hemophilia A. Patients (N=74) received once-weekly ALTUVIIIO (50 IU/kg) prophylaxis \nfor 52 weeks. The primary endpoint was the occurrence of factor VIII inhibitors. Secondary \nendpoints included annualized bleed rates (ABR) of treated bleeds, bleed treatment, joint health, \nquality of life, perioperative management, pharmacokinetics, and safety. \n \nAn ongoing extension study, XTEND-ed (NCT04644575) is evaluating the long-term safety and \nefficacy of ALTUVIIIO in previously treated patients with severe hemophilia A for up to four \nyears. \n \nAbout Hemophilia A \nHemophilia A is a rare condition in which the ability of a person’s blood to clot properly is \nimpaired, leading to excessive and spontaneous bleeds into joints that can result in joint damage \nand chronic pain, and potentially impact quality of life. Disease severity is determined by the \nlevel of clotting factor activity in a person’s blood, meaning there is a negative correlation \nbetween bleeding risk and factor activity levels. \n \nAbout Sanofi and Sobi collaboration \nSobi and Sanofi collaborate on the development and commercialization of Alprolix and \nElocta/Eloctate. The companies also collaborate on the development and commercialization of \nefanesoctocog alfa, or ALTUVIIIO in the US, Taiwan, and Japan and ALTUVOCT™ in Europe. Sobi \nhas final development and commercialization rights in the Sobi territory (essentially Europe, \nNorth Africa, Russia and most Middle Eastern markets). Sanofi has final development and \ncommercialization rights in North America and all other regions in the world excluding the Sobi \nterritory. \n \nAbout Sobi® \nSobi is a specialised international biopharmaceutical company transforming the lives of people \nwith rare and debilitating diseases. Providing reliable access to innovative medicines in the areas \nof haematology, immunology and specialty care, Sobi has approximately 1,800 employees \nacross Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted \n\n\n3/3 \n \nto SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at \nsobi.com and LinkedIn . \n \nAbout Sanofi  \nWe are an innovative global healthcare company, driven by one purpose: we chase the miracles \nof science to improve people’s lives. Our team, across the world, is dedicated to transforming \nthe practice of medicine by working to turn the impossible into the possible. We provide \npotentially life-changing treatment options and life-saving vaccine protection to millions of \npeople globally, while putting sustainability and social responsibility at the center of our \nambitions.  \nSanofi is listed on EURONEXT: SAN and NASDAQ: SNY \n \nMedia Relations \nSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com \nEvan Berland | +1 215 432 0234 | evan.berland@sanofi.com  \nNicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com  \nVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com \nTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com \n \nInvestor Relations \nThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com \nAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com \nArnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com \nFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com \nKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.com \nNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com \nTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com \nThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com \n \n \nSanofi Forward-Looking Statements \nThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. \nForward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding \nthe marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements \nare generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although \nSanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned \nthat forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and \ngenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or \nimplied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, \nunexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of \nthe product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including \nfuture clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or \nmanufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate \noutcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have \non us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our \nemployees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the \npublic filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding \nForward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by \napplicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.","difficulty":"easy","domain":"Multi-Document QA","length":"short","question":"Based on these press releases from Sanofi regarding their pharmaceutical products, which of the following products cannot usually be used to treat blood diseases?\n①ALTUVIIIO\n②Dupixent\n③Sarclisa\n④Tolebrutinib\n⑤Aubagio\n⑥Placebo","sub_domain":"Multi-news"}

Source: https://huggingface.co/datasets/zai-org/LongBench-v2

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