Posted by Michael Wonder on 06 Aug 2019
Dupixent (dupilumab) approved by European Commission for adolescents with moderate-to-severe atopic dermatitis
6 August 2019 - Only biologic approved in the European Union for patients aged 12 and above with moderate-to-severe atopic dermatitis.
The European Commission (EC) today extended the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The EC approval is based on clinical data from the LIBERTY AD program, including a pivotal Phase 3 trial and an open-label extension trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis.
