CHMP recommends approval of Dupixent in adolescents with moderate-to-severe atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), from Sanofi/Regeneron Pharma, recommending extending its approval in the European Union (EU) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. If approved, Dupixent would be the first biologic medicine approved in the EU to treat these patients. The positive CHMP opinion is based on clinical data from the LIBERTY AD program, including a pivotal Phase III trial and an open-label extension trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis. A final decision on the Dupixent application by the European Commission (EC) is expected in the coming months.

Comment: Dupixent, is the first and only biologic to show positive results as monotherapy in adolescents aged 12 to 17 years with inadequately controlled disease.