If approved, Dupixent would be the first and only targeted medicine in the EU for these young children
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
In Europe, about 80,000 children aged 6 months to 5 years with uncontrolled severe atopic dermatitis are candidates for systemic therapy
TARRYTOWN, N.Y. and PARIS, Jan. 27, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic…