Sanofi & Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Chronic Obstructive Pulmonary Disease (COPD)
Shots:
- The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same
- Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function improvements & improved health-related QoL at 52wks. which was significant & nominal in the BOREAS & NOTUS studies, respectively, as evaluated by SGRQ
- Additionally, Dupixent’s sBLA for the same indication has been accepted by the US FDA & received priority review with the decision expected on Sep 27, 2024. Other regulatory submissions are under review globally (incl. US & China)
Ref: Regeneron | Image: Regeneron
Related News:- Sanofi Highlights Data from the P-III (NOTUS) Study of Dupixent for COPD at ATS 2024 and Publishes in the NEJM
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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.
