Sanofi and Regeneron’s Dupixent Receives the US FDA’s and NMPA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)
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- The US FDA and NMPA have granted approval to Dupixent as an add-on maintenance therapy for treating inadequately controlled COPD with raised blood eosinophils
- 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
- Studies showed reduced annual moderate/severe COPD exacerbations by 30% (BOREAS) & 34% (NOTUS), improved post-bronchodilator FEV1 by 74mL & 68mL (maintained at 52wks.) and a 51% vs 43% & 47% response in health-related QoL was observed at 52wks. Pre-bronchodilator FEV1 also showed significant improvements at both time points
Ref: Regeneron | Image: Sanofi & Regeneron
Related News:- Sanofi and Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Eosinophilic Esophagitis (EoE) in Children
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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.
