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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