GSK’s Depemokimab Applications Accepted for FDA Review for Asthma and CRSwNP
If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing, according to GSK.
The US FDA has accepted GSK's Biologics License Application for depemokimab as an add-on maintenance treatment for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP), the company announced Monday.
If approved, depemokimab would be the first ultra-long-acting biologic with a twice-yearly dosing schedule. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025.
Clinical Trial Data Supports Applications
The submissions are based on findings from GSK’s SWIFT and ANCHOR phase 3 clinical trial programs. The SWIFT-1 and SWIFT-2 studies evaluated depemokimab as an add-on therapy for asthma with type 2 inflammation, demonstrating reductions in exacerbations and hospitalizations compared with placebo. The ANCHOR-1 and ANCHOR-2 trials assessed the biologic’s effect on CRSwNP, showing reductions in nasal polyp size and nasal obstruction symptoms.
Depemokimab is a monoclonal antibody that targets interleukin-5 (IL-5), a cytokine involved in type 2 inflammation, which is a major contributor to severe asthma and CRSwNP. The therapy’s extended half-life allows for dosing every 6 months.
“Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems,” Kaivan Khavandi, GSK’s senior vice president and global head of respiratory, immunology, and inflammation R&D, said in a March 3, 2025, press release.
Disease Burden and Treatment Landscape
Asthma affects over 26 million people in the US, with nearly 40% experiencing at least one exacerbation annually. Uncontrolled asthma contributes to approximately 100 000 hospitalizations and nearly 1 million emergency department visits each year. Meanwhile, chronic rhinosinusitis affects an estimated 2.1% of the US population, with nasal polyps present in up to 30% of these cases.
Depemokimab is currently being evaluated for additional IL-5-mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES), in separate phase III trials.
Depemokimab is not yet approved for use in any country.
