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Associated Press
18-04-2025
- Health
- Associated Press
Press Release: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Paris and Tarrytown, NY, April 18, 2025. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. Kenneth Mendez President and Chief Executive Officer at the Asthma and Allergy Foundation of America 'People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives. The approval of this treatment offers patients more options and the chance to control their disease.' Alyssa Johnsen, M.D., Ph.D. Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi 'CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living. This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.' The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both studies met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks. Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks. Study B (n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use. Safety results from Study A, Study B, and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions. George D. Yancopoulus, M.D., Ph.D. Board co-Chair, President and Chief Scientific Officer at Regeneron 'Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease. With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.' Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil. Submissions are currently under review with other regulatory authorities around the world including in the EU. About CSU CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of itch and 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. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines. About the Dupixent CSU phase 3 study program The LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU consists of Study A, Study B, and Study C. These studies were randomized, double-blind, placebo-controlled clinical studies that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone. Studies A and C were replicate studies that assessed patients aged six years and older who remained symptomatic despite the use of antihistamines. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three studies, patients received an initial loading dose followed by 300 mg Dupixent every two weeks, except for pediatric patients weighing <60 kg who received 200 mg every two weeks. In all three studies, the primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score, 0-21 scale). The key secondary endpoints (also assessed at 24 weeks) included change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale). Additional secondary endpoints assessed at 24 weeks evaluated the proportion of patients achieving well-controlled disease status (UAS7 ≤6) and the proportion of patients with complete response (UAS7=0). The results from Studies A and B were published in The Journal of Allergy and Clinical Immunology. Study B did not meet the primary endpoint in the US of reduction in ISS7 compared to placebo at 24 weeks. About Dupixent Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent 300 mg is administered every two weeks after an initial loading dose. In patients aged 12 to 17 years with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent is administered every two weeks based on weight (200 mg for adolescents ≥30 to <60 kg, 300 mg for adolescents ≥60 kg) after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In adolescents aged 12 to 17 years, Dupixent should be administered under the supervision of an adult. Dupixent 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 two of the key and central drivers of the type 2 inflammation that plays 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 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, CSU, and chronic obstructive pulmonary disease in different age populations. More than one million 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, bullous pemphigoid, and lichen simplex chronicus. 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 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 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Nicolas Obrist | +33 6 77 21 27 55 | [email protected] Léo Le Bourhis | +33 6 75 06 43 81 | [email protected] Victor Rouault | +33 6 70 93 71 40 | [email protected] Timothy Gilbert | +1 516 521 2929 | [email protected] Sanofi Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | +1 617 710 3587 | [email protected] Thibaud Châtelet | +33 6 80 80 89 90 | [email protected] Yun Li | +33 6 84 00 90 72 | [email protected] Regeneron Media Relations Ilana Yellen | +1 914-330-9618| [email protected] Regeneron Investor Relations Mark Hudson | +1 914-847-3482 | [email protected] 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 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, 2024. 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 except for 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) for the treatment of chronic spontaneous urticaria ('CSU'); 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 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 CSU in the European Union as well as for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, lichen simplex chronicus, 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 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; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); 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 on Regeneron's business; and risks associated with 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), 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), 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, 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 ( ) and its LinkedIn page ( ). Attachment
Associated Press
18-04-2025
- Health
- Associated Press
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. 'People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,' said Kenneth Mendez, President and Chief Executive Officer at the Asthma and Allergy Foundation of America. 'The approval of this treatment offers patients more options and the chance to control their disease.' 'Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,' said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. 'With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the U.S. with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.' The U.S. approval is based on data from two Phase 3 clinical trials, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both trials met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks. Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks. Study B (n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use. Safety results from Study A, Study B and Study C were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three trials, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions. 'CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,' said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. 'This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options.' Dupixent is already approved for CSU in Japan, the United Arab Emirates (UAE) and Brazil. Submissions are currently under review with other regulatory authorities around the world including in the European Union. About Chronic Spontaneous Urticaria CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of itch and 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. More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines. About the Dupixent CSU Phase 3 Trial Program The LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU consists of Study A, Study B and Study C. These trials were randomized, double-blind, placebo-controlled clinical trials that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone. Studies A and C were replicate trials that assessed patients aged 6 years and older who remained symptomatic despite the use of antihistamines. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three trials, patients received an initial loading dose followed by 300 mg Dupixent every two weeks, except for pediatric patients weighing <60 kg who received 200 mg every two weeks. In all three studies, the primary endpoint assessed the change from baseline in itch at 24 weeks (measured by the weekly itch severity score [ISS7], 0-21 scale). The key secondary endpoints (also assessed at 24 weeks) included change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale). Additional secondary endpoints assessed at 24 weeks evaluated the proportion of patients achieving well-controlled disease status (UAS7 ≤6) and the proportion of patients with complete response (UAS7=0). The results from Studies A and B were published in The Journal of Allergy and Clinical Immunology. Study B did not meet the primary endpoint in the U.S. of reduction in ISS7 compared to placebo at 24 weeks. About Dupixent Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent 300 mg is administered every two weeks after an initial loading dose. In patients aged 12 to 17 years with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent is administered every two weeks based on weight (200 mg for adolescents ≥30 to <60 kg, 300 mg for adolescents ≥60 kg) after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In adolescents aged 12 to 17 years, Dupixent should be administered under the supervision of an adult. Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) 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 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Regeneron and Sanofi are committed to helping patients in the U.S. 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 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 (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, CSU and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.1 About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, bullous pemphigoid and lichen simplex chronicus. 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. U.S. INDICATIONS DUPIXENT is a prescription medicine used: DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine. DUPIXENT is not used to treat any other forms of hives (urticaria). IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, or chronic spontaneous urticaria, and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: The most common side effects include: Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It's an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it's recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. Please see accompanying full Prescribing Information including Patient Information. 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 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. 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. 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Axios
07-04-2025
- Climate
- Axios
New Orleans is one of the country's allergy capitals
New Orleans is the second-worst place to live in the U.S. in terms of seasonal allergies, according to new data. Why it matters: We're currently in the midst of " The Pollening" in south Louisiana. The big picture: The worst cities are concentrated in the South and the East Coast, the Asthma and Allergy Foundation of America says. Wichita, Kansas, came in first for the third consecutive year. Baton Rouge ranked No. 14. See the full list. Between the lines: New Orleans ranked worse than average for pollen counts and over-the-counter medicine use but better than average for availability of health care professionals who specialize in allergies. Threat level: Recent pollen counts in New Orleans have been among the highest in the country as the region approaches the seasonal peak, according to Pollen-related allergies are what many people call " hay fever." Allergy symptoms vary by person, but they can include a runny nose, a stuffy nose, coughing, sneezing, watery eyes and nasal congestion. Seasonal allergies often make asthma symptoms worse, too. Zoom out: The New Orleans metro has four main allergy irritants, says Anna Timmerman, an LSU AgCenter assistant horticultural agent for St. Bernard Parish. Tree pollen is the primary offender at the start of the season with live oaks, pine, pecan, tallow, elm and cedar trees, she previously told Axios. Next up is ragweed, grass and mold. Ligustrum is a widely used ornamental shrub and causes allergy problems for some people. Magnolias, jasmine, gardenias and other blooming ornamentals usually don't bother people, she said. Zoom in: New Orleans leapfrogged up the rankings, mainly due to climate change, according to Kenneth Mendez, the president and CEO of the allergy foundation. Last year, New Orleans was ranked No. 34, based on 2023 data. He said New Orleans had a much higher weed pollen season in 2024, possibly due to increased moisture from Hurricane Francine, which made landfall in September. November was also the warmest on record in Louisiana, he said, which would have extended the growing season. State of play: Most major U.S. cities are suffering from longer allergy seasons amid human-caused climate change, according to new analysis from Climate Central. "Climate change makes pollen seasons not only longer, but also more intense due to heat-trapping pollution," per Climate Central's report. "Higher levels of planet-warming CO2 in the air can boost pollen production in plants, particularly in grasses and ragweed." How it works: To rank allergy capitals, the foundation looked at year-round pollen counts, over-the-counter allergy medicine use and availability of board-certified allergists/immunologists in the 100 most populated U.S. metros. Go deeper
Vox
31-03-2025
- Health
- Vox
Yes, your allergies are getting worse
is a correspondent at Vox writing about climate change, energy policy, and science. He is also a regular contributor to the radio program Science Friday. Prior to Vox, he was a reporter for ClimateWire at E&E News. The warming spring air is a welcome relief from the bitterly cold winter across much of the US, but millions of seasonal allergy sufferers are getting buried under a pollen tsunami, with sneezing, headaches, watery eyes, and stuffed sinuses sending them right back indoors. Already, Atlanta has broken its pollen count record, with 14,801 grains per cubic meter spewing from pine, oak, and birch trees. Houston also reported its highest pollen counts since 2013, when records began. Related Get ahead of allergy season this year The Asthma and Allergy Foundation of America (AAFA) projects that 2025 will be yet another brutal year for seasonal allergies across the country, with the worst-afflicted cities in the southern US. Your red eyes and runny noses don't deceive you — seasonal allergies are getting worse, a miserable reality for nearly one in three US adults and one in four children. Why? Sneezing and sniffles are some of the sirens of climate change. In fact, because of warming, pollen is now a nearly year-round menace in some parts of the US. Pollen, the main seasonal allergy trigger, is emerging earlier in the year, in higher concentrations, and lasting longer year after year. 'In the springtime, the first pollen allergens are from trees, and that is starting 20 days earlier than it did 30 years ago,' said Kenneth Mendez, CEO of AAFA. Rising concentrations of carbon dioxide in the atmosphere are directly inducing plants to produce more pollen while extending the temperature conditions that trigger pollen production in plants. 'We hear all the time, 'I've never had allergies before and now I suddenly feel like I have allergies,' or 'I feel like my allergies are getting a lot worse' and that's because the allergic load is that much higher because of climate change,' Mendez said. For most people, seasonal allergies are an unpleasant nuisance. But with millions feeling blergh at the same time, it adds up to a huge economic burden in lost productivity. Asthma, allergic rhinitis — the condition you probably know of as hay fever — and related allergy conditions cost the economy billions of dollars each year in lost work days, medications, and doctor's visits. There are also people for whom pollen is a more serious problem and can lead to dangerous complications or exacerbate other health issues. One study found that tree pollen allergies lead to 25,000 to 50,000 emergency room visits per year, two-thirds from people under the age of 18. Over time, as pollen counts increase, more people with a higher sensitivity threshold are finding out the hard way that these tiny grains are a hazard. Other people are also finding out that doors and windows can't protect them as some of the tiniest pollen grains seep in. 'If the trendlines continue, I think more people are going to feel miserable from allergies,' Mendez said. How we keep making allergies worse for ourselves The problem for allergy sufferers is that their body's defense mechanisms sometimes overreact to something benign. Usually, it leads to mild, easily treatable symptoms. But allergens can also trigger more serious complications like asthma attacks, causing wheezing, chest tightness, and shortness of breath. In rare cases, they can lead to anaphylaxis, a whole-body reaction where the airways can swell shut and blood pressure drops to dangerously low levels. The vast majority of pollen allergies are more annoying than dangerous, but seasonal pollen is so ubiquitous that it's almost impossible to avoid, sneaking indoors through vents, window seals, on clothing, and in pet fur. Some people are more sensitive than others, but the relentless, growing exposure can add up to misery even for those with mild allergies. Pollen grains range in size from 100 down to less than 10 microns, allowing them to penetrate deep into the lungs and irritate airways. Many types of plants release pollen as part of their reproductive cycle. Generally, trees spread pollen in the spring, grasses over the summer, and ragweed in the autumn. Airborne cloud of pine pollen from male pine cones in Arizona. Wild Horizons/Universal Images Group via Getty Images However, the historical pollen timing patterns have already shifted. Tree pollen is wafting off of branches earlier in the season almost every year. Some grass species have seen their pollen release days delayed by almost a month while their overall season has grown longer. As a result, grass pollen increasingly overlaps with the ragweed pollen season, which itself has been extended by more than three weeks in some parts of the country since 1995. There are two key mechanisms driving this trend, both induced by humanity's appetite for fossil fuels. Increasing concentrations of carbon dioxide in the atmosphere from burning coal, oil, and natural gas directly induce many plant species to produce more pollen. Carbon dioxide can make plants grow bigger and faster, and produce more flowers, which leads to more pollen. More pollen leads to more seeds, which means even more plants spraying pollen the next season. Higher levels of carbon dioxide in the atmosphere are also warming the planet and changing the climate. In general, that means warmer, shorter winters and earlier springs, which leads to longer growing seasons for plants. These trends will continue as global average temperatures go up, making allergies a significant public health burden. Some parts of the country, such as Texas, are on track to see pollen counts almost double by 2050 compared to 2000. It's not just pollen you have to worry about For many people, allergies are an added complication on top of other health and environmental conditions. Air pollution from ozone, particulates, sulfur, and nitrogen compounds can cause their own breathing problems, but when they intersect with allergies, they can make symptoms even worse. Pollution from roads can make pollen from nearby plants more potent at triggering allergic reactions. Smoke from wildfires can also exacerbate allergies. Cities may not offer much refuge. Changes to the landscape like urbanization can create a more favorable habitat for plants like ragweed. City centers also tend to warm up faster than their rural surroundings and experience higher concentrations of air pollutants, compounding the effects of allergies. These factors are especially potent in low-income and underserved communities. Pollen isn't the only allergen changing with the climate either. Rising temperatures and precipitation in some areas are increasing the number and duration of allergenic mold spores. Extreme weather further worsens the problem, as the damage and destruction create conditions for more mold. That was evident in New Orleans last year as storms like Hurricane Francine soaked the city. 'When these storms come through, they create so much damage over the landscape of the state. Some communities have resources to immediately move in and repair roofs and patch windows, and then we have a lot of folks that simply don't have those resources. With leaking roofs, you have mold growth indoors,' said John Carlson, who leads the high-risk allergy division at the Ochsner health system in New Orleans. 'Because it's so warm here, we can grow mold year round as long as there's moisture.' High winds from storms can also whip up dust, which can then trigger asthma. Additionally, there's a phenomenon called thunderstorm asthma, where the weather conditions can rupture pollen grains into smaller, more allergenic fragments, triggering asthma attacks. It's not clear whether the overall number of people with seasonal allergies is increasing. The US may be approaching a plateau in the number of people who are susceptible to pollen, Carlson said. At the same time, there are other conditions that can present with allergy-like symptoms, and at high enough concentrations, even people without allergies will wheeze. 'In New Orleans, we have a ton of oak pollen — I mean, just so much oak pollen in the air — and you commonly have a lot of people who don't have oak pollen allergy nevertheless with itchy eyes and the sneezing from just the irritant effect of the particles,' Carlson said. The good news is that there are ways to contain the worst effects of seasonal allergies. For people with a history of bothersome seasonal allergies, seeing an allergist and finding out what their specific triggers are and what medicines work is key. It may make sense to start taking medications like nose sprays or over-the-counter allergy drugs before pollen ramps up. Related 4 tips for dealing with a ferocious allergy season 'We generally say to have your medications in your system close to two weeks ahead of time because it takes some time to build up,' Mendez said. For people who don't know if they have allergies but are concerned about the threat, pay attention to your symptoms and see an allergist if you do start to experience irritated eyes and airways. There are also more aggressive interventions for people with severe allergies who don't respond to other medicines like desensitization therapy, also known as allergy shots. Some of the same measures for avoiding air pollution also work for pollen. Pay attention to pollen forecasts in your local area. Avoid being outside and close doors and windows during high pollen release times, particularly in the morning. Leave your coat and shoes outside or locked away before you settle down at home. Wipe down your dog after a walk. Use a HEPA air filter in your living spaces.
The Hill
18-03-2025
- Health
- The Hill
Allergy sufferers in these US cities face a tough 2025 season, study finds
(NEXSTAR) – With less than a week before the arrival of spring, allergy sufferers are bracing for the season, which will be especially bad in 20 U.S. cities, according to an Asthma and Allergy Foundation of America (AAFA) report released Tuesday. These 'allergy capitals' are located largely in the southern and eastern parts of the country, with Wichita, Kansas, taking the top spot for the third year in a row. The AAFA's 2025 Allergy Capitals study ranks the top 100 cities based on pollen scores for trees, grasses and weeds, along with over-the-counter medication usage and the number of local allergy specialists. What are wheat pennies, and why are they sometimes worth thousands? Kenneth Mendez, CEO and president of AAFA, told Nexstar that there are likely environmental reasons behind the outsized leaderboard presence of cities located in the southeastern U.S. 'Remember, we're looking at three things within the pollen counts – that's trees, weeds and grasses,' Mendez said. 'So there's three different seasons for that, and you find all those types of pollen in that region.' The cities projected to be the most insufferable when it comes to seasonal allergies in 2025 are: Wichita, KS New Orleans, LA Oklahoma City, OK Tulsa, OK Memphis, TN Little Rock, AR Raleigh, NC Richmond, VA Greenville, SC Greensboro, NC Virginia Beach, VA Augusta, GA Dallas, TX Baton Rouge, LA Winston-Salem, NC Chattanooga, TN Knoxville, TN Charlotte, NC Scranton, PA Jacksonville, FL You can see the full list of 100 cities on the Asthma and Allergy Foundation of America website. What's different in 2025? Eight California cities made dramatic jumps up the ranking, thanks to a 'grass and weed pollen explosion' the AAFA says was worsened by wet weather in 2024 that fed plant growth. Metropolitan Area 2025 Rank 2024 Rank Reason for the Change Sacramento, CA 23 94 Much higher grass pollen, higher weed pollen Bakersfield, CA 21 91 Much higher grass pollen, much higher weed Stockton, CA 24 93 Much higher grass pollen, higher weed pollen San Jose, CA 41 97 Much higher grass pollen, higher weed pollen Fresno, CA 28 78 Much higher weed pollen Oxnard, CA 33 75 Higher grass pollen, much higher weed pollen Los Angeles, CA 51 85 Higher grass pollen, much higher weed pollen San Francisco, CA 53 81 Higher weed pollen New Orleans also made a dramatic jump from the 34th spot last year to second place in 2025. According to the 2025 Allergy Capitals report, New Orleans saw a much higher weed pollen season, potentially made worse by additional water from Hurricane Francine, which made landfall on Sept. 11, 2024, as a Category 2 storm. The timing happened to coincide with the fall weed pollen season, according to the report, which was followed by abnormally warm temperatures that stretched the growing season. Why the allergy season is growing longer Pollen, the fine powder produced by plants as part of the reproduction process, is more abundant in warm weather, and experts say the season is only getting longer as our climate warms. A study cited by the National Institute of Environmental Health Services found that the northern U.S. pollen season lengthened by as much as 13 to 27 days between 1995 and 2009. 'Some parts of the United States now experience pollen (tree, grass or weed) year-round,' according to the AAFA report. 'Warmer temperatures also trap heat in urban areas, increasing air pollution and stimulating pollen production.' Fake antivirus software customers to receive $25M in payments While pollen causes a certain level of misery in all allergy sufferers, the season can be dangerous, even potentially life-threatening for some. 'There's something called allergic asthma, which is asthma that's triggered by seasonal allergies,' Mendez said. 'What a lot of people don't realize is that 10 people die each day from asthma, so it's really important to have your allergies under control if you have allergic asthma.' In 2022, there were 3,602 deaths caused by asthma, according to the Centers for Disease Control and Prevention. How to relieve allergy symptoms The first thing to figure out is what specifically you're allergic to, according to Dr. Nana Mireku, an allergist in the Dallas-Fort Worth area. Many Americans are allergic to several things at once; allergists can run tests for different triggers. Over-the-counter nasal sprays can help relieve symptoms, but they take a while to kick in, so it's best to start them in early March, Shah said. Antihistamines are another option. Shah said she's seen some patients benefit from switching to a similar brand if one stops working, but said that there isn't much broader data to back the recommendation. For young children and people who have to take many different allergy medications, immunotherapies in the form of shots and oral drops can help desensitize the immune system to allergens, treating symptoms at their root. 'We tell people all the time, understand what your triggers are,' Mendez said. 'The only way you could understand what your triggers are so you can manage your allergies is to see a specialist.'
