FDA accepts Dupixent for priority review for children aged 6 months to 5 years with moderate to severe atopic dermatitis.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) 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 June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication.
The sBLA is supported by data from the pivotal Phase III trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The trial met all primary and secondary endpoints, showing that Dupixent and TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone. Safety results were generally consistent with the safety profile of Dupixent in atopic dermatitis for patients aged 6 years and older. The most common adverse events that were more commonly observed with Dupixent included conjunctivitis and herpes viral infections.
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