Dupixent ( dupilumab) sBLA accepted by FDA for priority review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis
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 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. Dupixent 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 Dupixent 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 Dupixent 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 Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (greater then 3%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions and arthralgia.
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