FDA accepts sBLA for Dupixent as an add-on maintenance treatment for children with moderate-to-severe atopic dermatitis. Sanofi + Regeneron

The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) , from Sanofi + Regeneron, as an add-on maintenance treatment for children aged 6 to 11 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 is May 26, 2020.

Despite standard-of-care therapy, many young children with moderate-to-severe atopic dermatitis continue to experience uncontrolled, persistent symptoms. These children live with intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. Beyond the physical symptoms, moderate-to-severe atopic dermatitis can have a significant impact on health-related quality of life for children, as well as placing a burden on their families.

The sBLA for Dupixent in children is supported by data that includes pivotal Phase III results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) in children with severe atopic dermatitis. In the trial, children treated with Dupixent and TCS experienced significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone. Adverse events that were more commonly observed with Dupixent included conjunctivitis, nasopharyngitis and injection site reactions, which is consistent with the previously documented safety profile of Dupixent in older populations. Detailed results from this trial will be presented at an upcoming medical congress.