Shots:
- The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively
- SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed depemokimab vs PBO + SoC, ICS & controller in the above pts and demonstrated reduced exacerbations & hospitalization rates; data was published in The NEJM
- ANCHOR-1 (n=271) & ANCHOR-2 (n=257) trials evaluated depemokimab vs PBO in CRSwNP pts and met its co-1EPs showing reduced nasal polyp size and obstruction VRS mean score at 52wks. Data were presented on AAAAI & WAO 2025 and published in The Lancet
Ref: GSK | Image: GSK
Related News:- GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025
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