The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
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- 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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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
