FDA Approves Twice-Yearly Biologic for Severe Eosinophilic Asthma
The US Food and Drug Administration has approved depemokimab-ulaa (Exdensur) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma characterized by an eosinophilic phenotype.
Approval was based on results from the phase III SWIFT-1 and SWIFT-2 trials, which demonstrated sustained reductions in asthma exacerbations compared with placebo, both on top of standard of care. Over 52 weeks, depemokimab reduced annualized asthma exacerbation rates by 58% in SWIFT-1 and 48% in SWIFT-2. Patients receiving depemokimab experienced substantially fewer exacerbations than those receiving placebo, with annualized exacerbation rates of 0.46 versus 1.11 in SWIFT-1 and 0.56 versus 1.08 in SWIFT-2.
Reductions extended to more severe outcomes. In secondary analyses, exacerbations requiring hospitalization or emergency department visits occurred in 1% and 4% of depemokimab-treated patients across the two trials, compared with 8% and 10% in the placebo groups. A pooled analysis showed a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalization or emergency care. Across studies, depemokimab was well tolerated, with similar rates and severity of adverse events compared with placebo.
Depemokimab was engineered with an extended half-life to provide sustained suppression of disease-driving type 2 inflammation. According to GSK, this pharmacologic profile supports prolonged efficacy with infrequent dosing. “Physicians in the US now have the option to provide sustained protection from exacerbations…in just two doses a year,” said Kaivan Khavandi, SVP and Global Head of Respiratory, Immunology & Inflammation R&D at GSK.
Experts noted the potential implications for biologic uptake and adherence. Geoffrey Chupp, MD, said, “There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections…that reduces the frequency of doses and may improve overall health care utilisation.”
For immunologists, the key takeaway is the introduction of a validated, ultra-long-acting biologic option that may address persistent exacerbations while reducing treatment burden in severe eosinophilic asthma.
Reference
Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma. News Release. December 16, 2025. Accessed December 19, 2025. https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/
