Sanofi and Regeneron Pharmaceuticals Inc. said Dupixent helped improve severe atopic dermatitis symptoms in children, meeting the main goal of a late-stage study.
The phase 3 trial evaluated the safety and efficacy of Dupixent when added to standard-of-care topical corticosteroids for treating severe atopic dermatitis in children 6 to 11 years old, compared to topical corticosteroids alone.
Atopic dermatitis, the most common type of eczema, is a chronic inflammatory skin disease characterized by red and itchy skin.
Dupixent, in addition to standard-of-care topical corticosteroids, significantly helped improve overall disease severity, skin clearing, itching and health-related quality of life, the companies noted.
After 16 weeks, results showed that 33% of patients treated with Dupixent experienced clear or almost clear skin, versus placebo's 11%. In addition, 70% of the patients treated with Dupixent had 75% or greater skin improvement, compared to 27% for placebo.
The study's results will be used to back regulatory applications, beginning with the U.S. Food and Drug Administration in the fourth quarter. The companies also plan to present the study's detailed results at a future medical meeting.
Dupixent is already approved to treat certain adolescents with moderate-to-severe atopic dermatitis in the U.S. and EU. The drug is also approved in the U.S. for chronic rhinosinusitis with nasal polyps and as an add-on maintenance therapy of moderate-to-severe asthma in certain patients.
Tarrytown, N.Y.-based Regeneron and France's Sanofi are evaluating Dupixent in a range of clinical development programs for diseases driven by allergic and other type 2 inflammation.