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FDA Priority Review of Dupixent® (Dupilumab) for Adolescents with CRSwNP

May 13, 2024

On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).   The target action date for the FDA decision is 15 September 2024.  If the new indication is approved, it will be the first treatment in the US for adolescents with inadequately controlled CRSwNP.

This is the second sBLA for Dupixent® accepted for priority review this year, with an sBLA for a 6th indication of uncontrolled COPD in adults accepted in February 2024.