Phase 3 data for GSK’s depemokimab appear to support the biologic’s chances of US Food and Drug Administration (FDA) approval in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), according to analysis by GlobalData.

Depemokimab is a monoclonal antibody that targets interleukin-5 (IL-5) to reduce eosinophil-driven inflammation. The therapy is administered twice yearly by subcutaneous injection, positioning it as one of the least frequently dosed biologics in its class.

The drug has been evaluated in the pivotal Phase 3 SWIFT-1 and SWIFT-2 trials in asthma and the ANCHOR-1 and ANCHOR-2 trials in CRSwNP. GlobalData reported that efficacy and safety outcomes across these studies were consistent with regulatory expectations for approval. The Prescription Drug User Fee Act (PDUFA) decision date for both indications is set for 16 December 2025.

Irena Maragkou, senior healthcare researcher at GlobalData, said: “Experts say that depemokimab’s efficacy is broadly comparable to existing biologics and does not exceed competitors such as Dupixent. However, its ultra-long dosing schedule represents a significant differentiator in a highly competitive market.”

GlobalData’s forecast projects worldwide depemokimab sales to reach approximately $1.65 billion by 2031, driven largely by its convenience of administration and positioning across two major respiratory indications.

Depemokimab’s upcoming FDA decision was one of 20 key regulatory catalysts identified in GlobalData’s Catalyst Monitor Q4 2025 report, which tracks major pharmaceutical milestones expected this quarter. The report also highlights pending FDA reviews for Cytokinetics’ aficamten in hypertrophic cardiomyopathy, Aldeyra Therapeutics’ reproxalap in dry eye disease, and Sanofi’s tolebrutinib in primary progressive multiple sclerosis.