Regeneron and Sanofi Report the EC’s Approval of Dupixent to Treat Chronic Obstructive Pulmonary Disease (COPD)
Shots:
- The EC has approved Dupixent for COPD as an add-on maintenance therapy in patients on a combination of ICS, LABA, LAMA or LABA + LAMA where ICS is inappropriate. Review of other submissions is underway across the US, China & Japan
- Approval was based on P-III (BOREAS & NOTUS) trials of Dupixent (n=468 & 470) vs PBO (n=471 & 465) in moderate-to-severe COPD adult smokers (N=1,874; age: 40-80yrs. & 40-85yrs.) with type 2 inflammation. Data published in the NEJM
- Studies showed reduced annual moderate/severe COPD exacerbations by 30% (BOREAS) & 34% (NOTUS) post 52wks. and a lung function improvement of 160mL vs 77mL & 139mL vs 57mL at 12wks. (reached at wk.2 & 4), sustaining at 52wks. with an enhanced health-related QoL
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.
