GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
Shots:
- CHMP recommended GSK‘s depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26
- SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP) & hospitalization-requiring events by 72% (2EP) vs PBO + SoC. The AGILE OLE study confirmed sustained safety & efficacy with Q6W dosing over 2yrs.
- ANCHOR-1 (n=271) & ANCHOR-2 (n=257) trials assessed depemokimab vs PBO in CRSwNP pts on intranasal corticosteroids, which showed reduced nasal polyp size at 52wks. & improved nasal obstruction verbal response over Wks. 49-52
Ref: GSK | Image: GSK |Press Release
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