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Dupixent® (dupilumab) Pivotal Trial Meets All Primary and Secondary Endpoints Becoming First Biologic Medicine to Significantly Reduce Signs and Symptoms of Moderate-to-severe Atopic Dermatitis in Children as Young as 6 Months
TARRYTOWN, N.Y. and PARIS, Aug. 30, 2021 /PRNewswire/ -- Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, Aug. 30, 2021 /PRNewswire/ --\nDupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks \nMore than seven times as many patients treated with Dupixent plus topical corticosteroids (TCS) achieved clear or almost clear skin compared to TCS alone at week 16\nDupixent plus TCS reduced overall disease severity by 70% and itch by 49%\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal Phase 3 results from a trial evaluating Dupixent® (dupilumab) to treat moderate-to-severe atopic dermatitis in children aged 6 months to 5 years. The trial met its primary and all secondary endpoints, showing that Dupixent added to standard-of-care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone (placebo). Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis. \nThe data reinforce the well-established efficacy and safety profile of Dupixent in other age groups, including a lower observed rate of skin infections in the Dupixent group compared to placebo. During the 16-week treatment period, Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo). These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents and adults to date.\n\"Moderate-to-severe atopic dermatitis in infants and young children is incredibly distressing for patients and their caregivers, who manage painful and persistent itch, intensive daily skincare routines such as chlorine baths and wet wraps, as well as sleepless nights for children and their families,\" said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. \"In fact, when starting this trial, the disease covered more than half of children's bodies and nearly a third of patients had previously resorted to using immunosuppressive m...