27 January 2023 - Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent improved skin clearance, reduced overall disease severity and improved health-related quality of life.
The EMA’s CHMP adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.