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:Sanofi & Regeneron | Image:Sanofi & Regeneron | Press Release
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