Sanofi Highlights Data from the P-III (NOTUS) Study of Dupixent for COPD at ATS 2024 and Publishes in the NEJM
Shots:
- The P-III (NOTUS) trial assessed Dupixent's (n=470) safety & efficacy vs PBO (n=465) to treat moderate-to-severe COPD adult smokers. Its results also verified the P-III (BOREAS) study data, & were published in The NEJM
- The data showed reduced moderate/severe COPD exacerbations by 34% & respiratory symptom severity as well as improved health-related QoL at 52wks. plus depicted 139mL vs 57mL lung function at 12wks. with 115mL vs 54mL improvement sustained at wk.52
- Dupixent is under the FDA’s priority review (PDUFA date: Jun 27, 2024) as an add-on maintenance therapy in uncontrolled COPD adults with type 2 inflammation. Other submissions are under review in the EU & China, with ongoing discussions among other global regulatory authorities
Ref: Globenewswire | Image: Sanofi
Related News:- Sanofi and Regeneron Report the US FDA’s Acceptance of sBLA for Dupixent with Priority Review to Treat COPD with Type 2 Inflammation
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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.