The move is supported by data from a Phase 3 trial that evaluated the efficacy and safety of dupilumab in addition to standard-of-care topical corticosteroids.
The FDA has accepted a supplemental Biologics License Application through Priority Review for dupilumab (Dupixent) as an add-on maintenance treatment for moderate to severe atopic dermatitis in children aged 6 months to 5 years.1 It should be used in children whose atopic dermatitis is not adequately controlled via topical prescription therapies or those where topical therapies are not considered advisable. The FDA has set a target action data of June 9, 2022, for the agency’s decision.
The move is supported by data from a Phase 3 trial that evaluated the efficacy and safety of dupilumab in addition to standard-of-care topical corticosteroids in the treatment of uncontrolled moderate-to-severe atopic dermatitis in children aged 6 months to 5 years. The trial showed that dupilumab and topical corticosteroids led to significant improvement in skin clearance and reduction in both overall disease severity and itch within 16 weeks, when compared to just topical corticosteroids. The safety findings were consistent with the profile found in patients aged 6 years and older. Conjunctivitis and herpes viral infections were the among the commonly observed adverse events linked to dupilumab.
Bernard A. Cohen, MD, section editor for Dermcase and professor of Pediatrics and Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, said of the news, "The recent news by Regeneron regarding the acceptance by the FDA of the Priority Review for dupilumab (Dupixent) in children age 6 months to 5 years is exciting, since this is the only approved safe treatment for patients over 6 years old with moderate to severe atopic dermatitis not well controlled with topical steroids and other approved medications. Data from other countries including Europe and Japan, where it is already approved for younger patients, shows similar findings. We look forward to the targeted date for the FDA decision June 9, 2022!"