FDA Grants Priority Review to Dupilumab for Atopic Dermatitis in Children
Dupilumab has been granted priority review 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.
The FDA has accepted the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc) for Priority Review 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 therapy is currently indicated for uses in treating patients ages 12 years and older.
If the sBLA application is approved by the FDA, dupilumab would be the first biologic medicine available in the United States for children with this condition. The target action date for the FDA’s decision is May 26, 2020.
The sBLA is supported by data that includes pivotal phase 3 results on the efficacy and safety of dupilumab combined with topical corticosteroids (TCS) in children with severe atopic dermatitis. In the trial, children treated with dupilumab and TCS experienced significantly improved measures of overall disease severity, skin clearing, itching, and health-related quality of life compared with TCS alone.
Adverse events (AEs) more commonly observed with dupilumab and TCS included conjunctivitis, nasopharyngitis, and injection site reactions. These AEs are consistent with the previously documented safety profile of dupilumab in older populations.
The FDA previously granted Breakthrough Therapy designation to dupilumab for the treatment of severe atopic dermatitis in children aged 6 months to 11 years whose disease was not controlled on topical prescription medications.
Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from dupilumab clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.
FDA Accepts for Priority Review Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis [news release]. Tarrytown, NY; January 28, 2020: Regeneron.