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Dupixent® (dupilumab) Phase 3 Data at Revolutionizing Atopic Dermatitis Conference Show Significant Improvement in Severe Atopic Dermatitis for Children Aged 6 to 11 Years
TARRYTOWN, N.Y. and PARIS, April 3, 2020 /PRNewswire/ -- Patients who added Dupixent to topical corticosteroids improved skin clearance; average overall
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, April 3, 2020 /PRNewswire/ -- \nPatients who added Dupixent to topical corticosteroids improved skin clearance; average overall disease improved by approximately 80% based on mean EASI score\nData 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\nExpanded Dupixent indication in children aged 6 to 11 years currently under Priority Review with the FDA; decision expected by May 26, 2020\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results from a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) for children aged 6 to 11 years with uncontrolled severe atopic dermatitis. In the trial, Dupixent combined with standard-of-care topical corticosteroids (TCS) significantly improved disease signs, symptoms and health-related quality of life in these children. Detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on April 5. The companies previously announced topline positive results of this trial in August 2019. \n\"In my practice, I see children with severe atopic dermatitis struggling with intense, persistent itching and skin lesions covering much of their body, and caregivers who are desperate for additional treatment options that can help control this disease,\" 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, and principal investigator of the trial. \"Data from the 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.\" \nData 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 and TCS, compared to TCS alone. Itch is often described as...