The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Regeneron Pharmaceuticals & Sanofi) for Priority Review as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
The target action date for the FDA decision is September 15, 2024. Dupilumab is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled.
The sBLA in adolescents is supported by an extrapolation of efficacy data from two positive pivotal trials (SINUS-24 and SINUS-52) in adults with CRSwNP. These trials demonstrated that Dupilumab significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery, at 24 weeks compared to placebo. The sBLA was also supported by the safety data of Dupilumab in its currently approved indications for adolescents.
Safety results in both SINUS-24 and SINUS-52 were generally consistent with the known safety profile of Dupilumab in its approved indications. Adverse events more commonly observed with Dupilumab (≥3%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions and arthralgia.
