Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate to severe atopic dermatitis for these young children.
Regeneron Pharmaceuticals and Sanofi today announced that 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 months to 5 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 on this investigational use is 9 June 2022.
