Full Press Release Details
Dupixent (dupilumab) showed positive topline results in Phase 3
trial of children aged 6 to 11 years with severe atopic dermatitis
PARIS and TARRYTOWN, NY August 6, 2019 A pivotal Phase 3 trial evaluating Dupixent (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Dupixent is the first and only biologic to show positive results in this
pediatric atopic dermatitis population.
The topline data show that for children with severe atopic dermatitis (covering nearly 60% of their skin surface
on average), adding Dupixent to standard-of-care topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching and
health-related quality of life, compared to TCS alone. In addition, the safety data were consistent with the previously documented safety profile of Dupixent in older populations, including a numerically lower rate of skin infections compared to
The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are
very important because of the significant unmet needs in this patient population. Children in the trial had suffered from severe atopic dermatitis for most of their lives, said George D. Yancopoulos, M.D., Ph.D., President and Chief
Scientific Officer of Regeneron. The trial showed that Dupixent significantly improved outcomes and quality of life, with no new safety signals.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that
IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin.
The unrelenting symptoms of this disease, which impact not just the child but the whole family, include widespread rashes, intense and persistent itching, and skin lesions, said John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. Symptoms of severe atopic dermatitis can take a toll on children both physically and emotionally. We are encouraged by these results, which demonstrate
that Dupixent improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients.
The primary endpoints assessed the proportion of patients achieving an Investigator s Global Assessment
(IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75, the co-primary endpoint outside of the U.S.) at 16 weeks.
Results at 16 weeks included:
16-week treatment period, the overall rates of adverse events were 65% for Dupixent every four weeks, 67% for Dupixent every two weeks and 73% for placebo. Adverse events that were more commonly observed with
Dupixent included conjunctivitis (7% for Dupixent every four weeks, 15% for Dupixent every two weeks and 4% for placebo), nasopharyngitis (13% for Dupixent every four weeks, 7% for Dupixent every two weeks and 7% placebo) and injection site
reactions (10% for Dupixent every four weeks, 11% for Dupixent every two weeks and 6% for placebo). Additional prespecified adverse events included skin infections (6% for Dupixent every four weeks, 8% for Dupixent every two weeks and 13% for
placebo) and herpes viral infections (2% for Dupixent every four weeks, 3% for Dupixent every two weeks and 5% for placebo).
Detailed results from this
trial will be presented at a future medical meeting and data will be submitted to regulatory authorities, starting with the U.S. Food and Drug Administration (FDA) in 4Q 2019. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent
for the treatment of moderate-to-severe (12 to 17 years of age) and severe (6 months to 11 years of age) atopic dermatitis. The efficacy and safety of Dupixent in
children below the age of 12 has not been reviewed by any regulatory authority.
About the Dupixent Pediatric Trial
The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent combined with TCS in children with severe atopic
dermatitis. The trial enrolled 367 patients aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications. In total, 92% of these patients suffered from at least one concurrent condition
such as allergic rhinitis, asthma and food allergy.
All patients received TCS throughout the trial. Patients were randomized into one of three treatment groups
for the 16-week treatment period: Dupixent subcutaneous injection 300 mg every four weeks (with an initial dose of 600 mg); Dupixent 100 mg or 200 mg every two weeks, based on weight (100 mg for <30 kg, 200
mg for 30 kg), with an initial dose of 200 mg or 400 mg, respectively; and placebo every two or four weeks.
Dupilumab Development Program
currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma and atopic dermatitis (6 to
11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase 2/3), chronic obstructive pulmonary disease (Phase 3) and food and environmental allergies (Phase 2). Dupilumab is also
being studied in combination with REGN3500 (SAR440340), which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.
Dupilumab is being jointly developed by Sanofi and Regeneron under global collaboration agreement.
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 disease, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain 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
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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
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prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare