USFDA updates Sanofi Dupixent label for atopic dermatitis

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer, Regeneron said, “We rely heavily on our hands and feet throughout the day, making atopic dermatitis particularly disruptive for patients who experience constant itch and painful cracking and bleeding skin lesions on these critical areas of the body. Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial U.S. approval in 2017, and we are pleased that Dupixent is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease.”

The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial. In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). At 16 weeks, patients treated with Dupixent experienced the following:

• 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint
• 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint

Results from this Phase 3 trial were most recently accepted in the Journal of the American Academy of Dermatology.

The safety results were generally consistent with the known safety profile of Dupixent in atopic dermatitis. Most common adverse events (AEs) observed with Dupixent (≥1%) in atopic dermatitis include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye and eosinophilia.