Posted by Michael Wonder on 08 Mar 2019
FDA to undertake priority review of Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps
8 March 2019 - The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.
The target action date for the FDA decision is 26 June 2019.
The application is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe chronic rhinosinusitis with nasal polyps despite previous treatment with surgery and/or systemic corticosteroids.
