Sanofi: Dupixent® (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 years

Dupixent (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 years

Detailed data to be presented at the Revolutionizing Atopic Dermatitis Conference show adding Dupixent to topical corticosteroids improved skin clearance; average overall disease improved by approximately 80%

Data further reinforce consistent safety and tolerability profile observed across adult and adolescent atopic dermatitis trials, including a numerically lower rate of skin infections compared to placebo

Expanded Dupixent indication in children aged 6 to 11 years currently under Priority Review with the FDA; decision expected by May 26, 2020

Paris and Tarrytown, NY a?? April 3, 2020 a?? The pivotal Phase 3 clinical trial results announced today show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. Sanofi and Regeneron previously announced topline positive results of this trial in August 2019. A Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5.a??In my practice, I see children with severe atopic dermatitis struggling with intense, persistent itching and skin lesionsA covering much ofA their body, and caregivers who are desperate for additional treatment options that can help control this disease,a??A said Amy S. Paller, M.D.,Walter J. Hamlin Professor and Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine andA principalA investigator of the trial. a??Data fromthe Phase 3 trial in children aged 6 to 11 adds to the established efficacy and safety data in adults and adolescents and provides hope to physicians and families for a potential new treatment option for children with this chronic disease.a??A 

Data to be presented at RAD show that at 16 weeks, nearly three times as many children achieved clear or almost clear skin when treated with Dupixent and TCS, and more than two-thirds experienced at least a 75% overall improvement of their disease compared to TCS alone. Additionally, more than three times as many children experienced a significant reduction in itch with Dupixent compared to TCS alone. Itch is often described as the most burdensome symptom of atopic dermatitis. Improvements in itch and disease severity were observed with Dupixent as early as two weeks after the first dose and continued throughout active treatment. A 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). Across all approved indications in the U.S., more than 100,000 patients have started treatment with Dupixent.
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