CAMBRIDGE, MA and TARRYTOWN, NY – March 1, 2019 - A diverse set of clinical and real-world data will be presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting from March 1 to 5 in Washington, D.C.
“The data presented at AAD 2019 build upon the established body of knowledge around the efficacy and safety of Dupixent, which has been used to treat nearly 50,000 patients with inadequately controlled moderate-to-severe atopic dermatitis since its approval nearly two years ago,” said Neil Graham, M.D., Vice President of Program Direction at Regeneron.
Presentations on Dupixent® (dupilumab) include results from a pooled analysis of the Phase 3 clinical trials (SOLO 1 and SOLO 2) in adult patients with moderate-to-severe atopic dermatitis and a Phase 3 trial that evaluated the efficacy and safety of Dupixent in adolescents with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies. Results from a real-world study of the disease and economic burden of atopic dermatitis will also be presented.
This new information provides patients and their doctors additional insight into the impact of Dupixent on symptoms and its potential to improve quality of life in moderate-to-severe atopic dermatitis,” said Naimish Patel, M.D., Vice President and Global Program Head for Dupilumab at Sanofi. “Our research across clinical and real-world evidence reinforces that it’s important to capture the diverse signs, symptoms and quality-of-life impact of atopic dermatitis, which goes beyond a single score.”
Sanofi and Regeneron joint presentations at AAD include:
Jerry Bagel, Mar 2/10:20-10:25/10198
Elena Rizova, Mar 2/10:05-10:10/9761
April W. Armstrong, Mar 2/9:05-9:10/8680
Amy S. Paller, Mar 1-Mar 2/9:00-17:00/10051
Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). The findings from the Dupixent trials presented at AAD in atopic dermatitis, as well as from prior trials in asthma and chronic rhinosinusitis with nasal polyps, demonstrate that both IL-4 and IL-13 are two key proteins that play a central role in type 2 inflammation, which seems to underlie atopic dermatitis as well as several other allergic diseases.
In the U.S., Dupixent is approved for treatment of adult patients with moderate-to-severe atopic dermatitis that is not well controlled by topical prescription therapies, or who cannot use topical therapies; Dupixent is also approved for use with other asthma medicines for maintenance treatment of moderate-to-severe asthma in people aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Other potential uses for Dupixent are investigational and the safety and efficacy have not been evaluated by the U.S. Food and Drug Administration, the European Medicines agency or any other regulatory authority. Dupilumab is being developed jointly by Sanofi and Regeneron as part of a global collaboration agreement.
Dupilumab development program
In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad clinical development program assessing a range of diseases driven by allergic and other type 2 inflammation, including pediatric (6 to 11 years of age) atopic dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase 3 completed), eosinophilic esophagitis (Phase 2/3), and food and environmental allergies (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.
For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.
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. If you are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.
DUPIXENT can cause serious side effects, including:
The most common side effects include injection site reactions, pain in the throat (oropharyngeal pain) and cold sores in your mouth or on your lips. Eye and eyelid inflammation, including redness, swelling and itching have been seen in patients who have atopic dermatitis.
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. If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In adolescents with asthma 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.
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 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, 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, neuromuscular diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and 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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These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) Injection; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, such as dupilumab for the treatment of pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, food and environment allergies, chronic obstructive pulmonary disease, and other potential indications (as well as in combination with REGN3500); unforeseen safety issues resulting from the administration of products and product candidates (such as dupilumab) in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products (such as Dupixent), research and clinical programs, and business, including those relating to patient privacy; 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 product candidates, including without limitation dupilumab; the availability and extent of reimbursement of the Company’s products (such as Dupixent) 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; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates (such as Dupixent) and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of any such products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s products and product candidates; 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 or collaboration agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. 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