GSK’s Phase III depemokimab data to support FDA approval

UK pharma major GSK’s (LSE: GSK) clinical data for depemokimab positions the asset for potential Food and Drug Administration (FDA) approval in asthma and chronic rhinosinusitis, according to reporting by the insights investigative news team at GlobalData.

Depemokimab acts by targeting interleukin-5 (IL-5) to reduce eosinophil-driven inflammation and is administered as a twice-yearly subcutaneous injection. The asset has been assessed in the pivotal Phase III SWIFT-1 and SWIFT-2 asthma trials, alongside the ANCHOR-1 and ANCHOR-2 studies in chronic rhinosinusitis with nasal polyps (CRSwNP), with results showing efficacy and safety consistent with FDA approval requirements.

Depemokimab’s Prescription Drug User Fee Act (PDUFA) decision date for asthma and CRSwNP is set for December 16, 2025. The Phase III data for depemokimab support the likely FDA approval in both indications; however, its success could hinge on its twice-yearly dosing convenience.