The European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged six months to 5 years old who are candidates for systemic therapy, according to Regeneron Pharmaceuticals, Inc. and Sanofi.
Dupixent is the first and only targeted medicine approved in Europe and the United States to treat these young children.
The approval is based on data from a Phase 3 trial in 162 children aged six months to 5 years with moderate-to-severe atopic dermatitis who received Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo). In the overall enrolled population, Dupixent improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to the placebo. (Blurb)
In both the general and severe populations, Dupixent improved sleep quality, skin pain, and health-related quality of life when compared to a placebo. Long-term efficacy data revealed that the clinical benefit observed at 16 weeks was sustained for 52 weeks.
Injection site reactions, conjunctivitis, allergic conjunctivitis, arthralgia, oral herpes, and eosinophilia are the most common side effects across indications. The trial's safety results were generally consistent with Dupixent's known safety profile in its approved indications; adverse events more commonly observed (5%) with Dupixent compared to placebo included eosinophilia and conjunctivitis. The long-term safety profile was comparable to the safety profile observed at 16 weeks and consistent with what was observed in older patients with atopic dermatitis.
