FDA approves dupilumab for atopic dermatitis treatment in pediatrics

The US Food and Drug Administration has approved dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of moderate-to-severe atopic dermatitis in children aged 6 to 11 years. According to Sanofi, dupilumab is the only biologic approved for this patient population following the approval.

The approval was based on the results of a phase 3 clinical study. The results of the study showed that children who were treated with dupilumab and topical corticosteroids had significant improvement in overall disease severity, skin clearance, and itch.

For more on the approval, check out our sister publication Drug Topics.