FDA Priority Review for Dupixent sBLA

FDA has accepted for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA 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 agency has set a user fee review action target date of 9/15.

The submission is supported by an extrapolation of efficacy data from two positive pivotal trials (SINUS-24 and SINUS-52) in adults with CRSwNP, according to the companies. “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,” they say.

On the safety side, SINUS-24 and SINUS-52 saw data that were generally consistent with Dupixent’s known safety profile. Adverse events more commonly observed with the therapy include injection site reactions and arthralgia.