GSK (NYSE:GSK) announced the U.S. Food and Drug Administration (FDA) approval of Exdensur (depemokimab), a novel, long-acting biologic treatment for severe asthma with an eosinophilic phenotype.
The approval, granted on Dec. 16, 2025, is based on positive results from the Phase III SWIFT-1 and SWIFT-2 trials, which demonstrated a significant reduction in asthma exacerbations with just two doses per year of the drug.
Depemokimab, a selective Sigma-1 receptor antagonist, showed a 58% and 48% reduction in the annualized rate of asthma exacerbations in the SWIFT-1 and SWIFT-2 trials, respectively.
Patients treated with depemokimab also experienced fewer exacerbations requiring hospitalization or emergency department visits, with a 72% reduction in the annualized rate of clinically significant exacerbations.
The approval of Exdensur introduces a much-needed treatment option for the approximately 2 million Americans suffering from severe asthma, particularly those who have been inadequately managed by existing therapies.
The drug’s twice-yearly dosing schedule addresses a significant unmet need in the asthma market, where biologics are often underutilized due to the frequency of injections required with current treatments.
With this approval, GSK is positioning Exdensur as a game-changing therapy that could reduce healthcare utilization and improve patient compliance, particularly in the most difficult-to-treat asthma populations.
The company plans to expand the treatment’s availability with upcoming regulatory decisions in Europe, China, and Japan, with a positive opinion from the European Medicines Agency’s CHMP already received.
The global roll-out is expected to help address the growing demand for innovative asthma treatments.