CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis

CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis

• Recommendation based on pivotal trial that showed Dupixent plus topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearance, itch and health-related quality of life measures, compared to TCS alone
• Data further reinforce the well-established safety profile of Dupixent in adult and adolescent atopic dermatitis patients
• Dupixent would be the first biologic medicine available in the EU to treat this patient group and remains the only biologic medicine approved in moderate-to-severe atopic dermatitis for adolescents and adults

PARIS and TARRYTOWN, NY – October 16, 2020 – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), recommending to extend the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy.

Dupixent is the first and only biologic approved for the treatment of uncontrolled moderate-to-severe atopic dermatitis for ages 12+ in the EU and ages 6+ in the U.S.

Dupixent is also approved in the EU for certain patients with severe asthma and severe chronic rhinosinusitis with nasal polyps, two other type 2 inflammatory diseases.

The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The positive CHMP opinion is supported by data that include pivotal Phase 3 results on the efficacy and safety of Dupixent combined with TCS in children aged 6 to 11 years with severe atopic dermatitis that is uncontrolled on topical prescription therapies. In the trial, children treated with Dupixent and TCS experienced significantly improved measures of overall disease severity (Eczema Area and Severity Index), skin clearance, itch and health-related quality of life measures, compared to TCS alone. Adverse events more commonly observed with Dupixent included conjunctivitis, nasopharyngitis and injection site reactions. These data are consistent with the well-established efficacy and safety profile of Dupixent observed across adult and adolescent atopic dermatitis trials. The use of Dupixent in children aged 6 to 11 years is investigational and its efficacy and safety has not yet been fully evaluated in the EU.