February 1, 2022
Positive Dupixent® (dupilumab) data across five diseases with underlying type 2 inflammation will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting from February 25 to 28. The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Additionally, positive results from two Phase 3 trials in a sixth indication, prurigo nodularis, were recently announced and will be presented at a separate medical meeting later this year.
Abstracts being presented at the AAAAI meeting have been published in an online supplement to The Journal of Allergy and Clinical Immunology and include:
New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. The use of Dupixent in these diseases is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.
New analyses evaluate Dupixent in patients aged six years and older with moderate-to-severe asthma. These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations.
New analyses assess Dupixent in reducing the burden of disease for patients with CRSwNP. These include assessments on the reduction of systemic corticosteroid use and symptoms, such as loss of sense of smell and nasal congestion, as well as the increase in days with no symptoms.
In addition to the late-breaking abstract, a new analysis assesses the impact of Dupixent treatment on biomarkers of type 2 inflammation in patients with EoE. The use of Dupixent in EoE is investigational and has not been approved by any regulatory authority.
New data from a trial that evaluated improvements in skin barrier function for adults and adolescents with moderate-to-severe atopic dermatitis treated with Dupixent, as well as long-term safety results of Dupixent in adults, will be shared.
In addition, results from an observational study highlight the disease burden of moderate-to-severe atopic dermatitis and unmet need in children.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Dupixent is not an immunosuppressant and does not require lab monitoring. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.
Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 350,000 patients have been treated 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 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, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), bullous pemphigoid (Phase 3), chronic inducible urticaria-cold (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). 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.
DUPIXENT is a prescription medicine used:
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
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 or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine 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 www.fda.gov/medwatch, 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 under 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all 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, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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