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Dupixent pivotal trial meets all endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months.- Regeneron + Sanofi.

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Published:31st Aug 2021
Regeneron Pharmaceuticals, Inc. and Sanofi announced positive pivotal Phase III 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.

The 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 III clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents and adults to date.

"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 medicines. These data show that Dupixent dramatically reduced the impact of atopic dermatitis on the lives of these young children and their families, with rapidly cleared skin, improved itch and improved observed patient outcomes, including sleep and skin pain. Importantly, Dupixent provided its benefits without acting as a broad immunosuppressant. In fact, Dupixent-treated patients experienced nearly 70% fewer skin infections compared to placebo patients.".

Condition: Atopic Dermatitis (Eczema)
Type: drug

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