GSK Reports the US FDA’s Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD
Shots:
- The US FDA has accepted regulatory submission of Nucala as an add-on treatment for COPD with eosinophilic phenotype (PDUFA date: May 7, 2025), based on MATINEE study
- The MATINEE study assessing Nucala vs PBO in COPD patients (n=804) with type 2 inflammation achieved its 1EP, showing significantly reduced moderate/severe exacerbations over 52-104wks. Full data will be highlighted at future conferences & support global regulatory submissions
- Additionally, Nucala is approved in the US as an add-on maintenance therapy for severe asthma with eosinophilic phenotype (≥6yrs.) & chronic rhinosinusitis with nasal polyps (CRSwNP) adults, eosinophilic granulomatosis with polyangiitis (EGPA) adults & hypereosinophilic syndrome (≥12yrs.)
Ref: GSK | Image: GSK
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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.
