GSK plc has announced that the US Food and Drug Administration has approved Exdensur, also known as depemokimab-ulaa, as an add-on maintenance treatment for patients aged 12 years and older with severe asthma characterized by an eosinophilic phenotype. The approval is supported by results from the phase III SWIFT-1 and SWIFT-2 trials, which showed that depemokimab administered twice yearly provided sustained reductions in asthma exacerbations compared with placebo alongside standard of care. In SWIFT-1, patients receiving depemokimab experienced a 58 percent reduction in annualized exacerbations while SWIFT-2 showed a 48 percent reduction over 52 weeks. The trials also demonstrated that depemokimab was generally well tolerated with side effects similar to placebo.

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Secondary endpoints indicated that depemokimab led to fewer exacerbations requiring hospitalization or emergency department visits. A pooled analysis from both trials showed a 72 percent reduction in clinically significant exacerbations needing hospital or emergency care over one year compared with placebo, highlighting the potential of depemokimab to reduce healthcare burden.

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Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology, and Inflammation Research and Development at GSK, stated that Exdensur now offers physicians in the United States a new option to provide sustained protection from severe asthma exacerbations with only two doses per year. He emphasized that the therapy could transform patient care and reinforce the role of biologics for individuals who continue to experience attacks despite current treatments.

Depemokimab is designed with an extended half-life, enabling long-term suppression of type 2 inflammation, which drives eosinophilic asthma. The therapy’s dosing schedule could improve patient adherence and reduce the overall burden on healthcare systems. Severe asthma affects approximately two million Americans, with half continuing to experience frequent exacerbations that may lead to hospitalizations and increased healthcare costs. Despite the benefits of biologics, only 20 percent of eligible patients in the United States currently receive them, leaving many at risk of uncontrolled disease. Longer dosing intervals are considered beneficial by both patients and physicians, with surveys indicating that 73 percent of healthcare providers believe extended intervals improve treatment adoption.

Geoffrey Chupp, Professor of Medicine in Pulmonary, Critical Care, and Sleep Medicine at Yale University, noted that many current biologic treatments are underutilized because frequent injections can be inconvenient and lead to inconsistent use. He highlighted that Exdensur offers longer protection between doses, which may help patients achieve their treatment goals while reducing the number of injections and overall healthcare utilization.

Tonya Winders, President and Chief Executive Officer of the Global Allergy and Airways Patient Platform, commented that patients with severe asthma face ongoing challenges with persistent symptoms and exacerbations. She welcomed Exdensur as an innovative option that provides long-acting protection with fewer doses, offering a meaningful improvement for patients with eosinophilic asthma.

Depemokimab has also received a positive opinion from the European Medicines Agency’s CHMP, with approval expected in the first quarter of 2026, and regulatory submissions are ongoing in other regions including China and Japan. Severe asthma is defined as asthma that remains uncontrolled despite medium- to high-dose inhaled corticosteroids plus an additional therapy or requires these treatments to maintain control. Type 2 inflammation, which elevates eosinophil levels, drives pathology in the majority of patients with severe asthma.

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