Sanofi and Regeneron Report the US FDA’s Acceptance of sBLA for Dupixent with Priority Review to Treat COPD with Type 2 Inflammation
Shots:
- The US FDA has accepted & granted priority review to the sBLA of Dupixent as an add-on maintenance therapy for uncontrolled COPD adults having type 2 inflammation with the decision expected on Jun 27, 2024. The regulatory submissions in China & the EU are under review
- The sBLA plus the worldwide submissions are based on P-III studies determining Dupixent's safety & efficacy in uncontrolled COPD with type 2 inflammation adult smokers (current/former) already on background maximal SoC inhaled therapy
- The studies (BOREAS, NOTUS) depicted moderate/severe acute COPD exacerbation reduction by 30% & 34% with Dupixent respectively vs PBO, and a sustained improvement in lung function at 52wks.
Ref: Globe Newswire | Image: Sanofi
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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.
