Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNYNF,SNY) said Monday that a pivotal phase 3 trial, which evaluated Dupixent or dupilumab to treat moderate-to-severe atopic dermatitis in children aged 6 months to 5 years, met its primary and all secondary endpoints.
The trial results showed that Dupixent added to standard-of-care topical corticosteroids significantly reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to topical corticosteroids alone or placebo.
Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks. Dupixent plus topical corticosteroids reduced overall disease severity by 70% and itch by 49%.
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 companies said in a statement.
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