The FDA has approved Sanofi’s and Regeneron’s Dupixent (dupilumab) for treatment of children ages 6 to 11 years with moderate-to-severe atopic dermatitis when topical therapies are inadequate.

The approval was based on the results of a phase 3 trial in which Dupixent with topical corticosteroids demonstrated significant improvements in overall disease severity, skin clearance and itch compared to topical corticosteroids alone.

Dupixent is the only biologic approved for this indication. The FDA granted the drug priority review and breakthrough therapy designations.