Regeneron and Sanofi Report the US FDA’s sBLA Acceptance of Dupixent to Treat Chronic Rhinosinusitis with Nasal Polyposis (CRSWNP)
Shots:
- The US FDA has accepted & granted priority review to the sBLA of Dupixent (dupilumab) as an add-on maintenance therapy for treating inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adolescents (12-17yrs.) with the decision anticipated on Sep 15, 2024
- The sBLA was based on safety & efficacy results from 2 CRSwNP studies (SINUS-24 & SINUS-52) in adults, depicting improvement in nasal congestion/obstruction severity, nasal polyp size & sense of smell plus minimizing the necessity for systemic corticosteroids or surgery at 24wks. vs PBO
- The safety results aligned with its known safety profile in approved indications & the AEs (≥3%) reported were injection site reactions & arthralgia
Ref: Regeneron | Image: Regeneron
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
