GSK Receives Approval for Exdensur (depemokimab) to Treat Severe Asthma
Wednesday, December 17, 2025
GSK has announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adults and adolescents aged 12 years and above.
Severe asthma is defined as asthma that remains uncontrolled despite treatment with medium- or high-dose inhaled corticosteroids and additional therapies, or that requires such treatment to prevent loss of control. Type 2 inflammation, often associated with elevated eosinophil levels, is present in the majority of patients with severe asthma.
Severe asthma affects around two million people in the United States, with many continuing to experience frequent exacerbations despite existing treatments. Although biologic therapies are available, only a minority of eligible patients currently receive them. Longer dosing intervals may improve treatment uptake and adherence among both patients and clinicians.
Exdensur is an ultra-long-acting biologic therapy designed for respiratory diseases driven by type 2 inflammation. Its extended half-life enables twice-yearly dosing, offering a potential new option for long-term asthma control.
Depemokimab has been developed as a long-acting biologic with an extended half-life, allowing dosing every six months. This approach aims to maintain long-term control of type 2 inflammation, a key driver of severe asthma, while reducing treatment burden for patients and healthcare systems.
The approval is supported by results from the Phase III SWIFT-1 and SWIFT-2 clinical trials. Across both studies, depemokimab significantly reduced asthma exacerbations compared with placebo when added to standard of care. Patients receiving depemokimab, administered twice yearly, achieved sustained protection from exacerbations over a 52-week period. The trials showed reductions of 58% and 48% in annualised asthma exacerbation rates in SWIFT-1 and SWIFT-2, respectively.
Secondary analyses indicated that fewer patients treated with depemokimab experienced exacerbations requiring hospitalisation or emergency department visits compared with those receiving placebo. A pooled analysis of both trials demonstrated a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospital or emergency care. Depemokimab was generally well tolerated, with a safety profile comparable to placebo.
In Europe, depemokimab has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), with a regulatory decision expected in the first quarter of 2026.
Regulatory reviews are also ongoing in other regions, including China and Japan.
Source: gsk.com
