Posted by Michael Wonder on 28 Jan 2020
FDA accepts for priority review Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
28 January 2020 - If approved, Dupixent would be the first biologic medicine available in the U.S. for these children.
The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The target action date for the FDA decision is 26 May 2020.
The application is supported by data that includes pivotal Phase 3 results on the efficacy and safety of Dupixent combined with topical corticosteroids in children with severe atopic dermatitis.
