Aventis Groupe: Press Release: Dupixent® (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis

Dupixent® (dupilumab) recommended for expanded EU approval by the CHMP totreat children as young as six months old with severe atopic dermatitis

  • 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 old with uncontrolled severe atopic dermatitis are candidates for systemic therapy

Paris and Tarrytown, N.Y. January 27, 2023. 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…



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