GSK has received approval from the U.S. Food and Drug Administration (FDA) for its anti-IL-5 antibody, depemokimab, marketed as Exdensur, for the treatment of severe eosinophilic asthma in patients aged 12 years and older. The therapy is designed to be used as an add-on or maintenance treatment and is administered through a subcutaneous injection every six months.
The approval was based on data from two Phase III clinical trials, SWIFT-1 and SWIFT-2. According to results published in The New England Journal of Medicine in September 2024, Exdensur reduced the rate of annualized asthma exacerbations by 58% in SWIFT-1 and by 48% in SWIFT-2 compared to placebo. Additionally, the drug demonstrated a reduction in exacerbations leading to hospitalizations or emergency visits across both studies. Adverse events were reported at similar rates and severity between patients receiving Exdensur and those given placebo.
Kaivan Khavandi, global head of Respiratory, Immunology and Inflammation R&D at GSK, stated: “Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma.” He added that Exdensur “could redefine patient care” for this condition.
Exdensur functions by blocking IL-5 cytokine, which plays a role in the differentiation, growth, activation, and survival of eosinophils—a type of white blood cell involved in inflammation—addressing an underlying pathological mechanism of asthma.
While GSK also sought FDA approval for Exdensur’s use in chronic rhinosinusitis with nasal polyps (CRSwNP), this indication was not granted according to Reuters. However, a company spokesperson indicated that GSK will continue discussions with regulators regarding this potential use. Data supporting CRSwNP included results from ANCHOR-1 and ANCHOR-2 trials showing significant improvements over placebo.
In addition to its U.S. approval for asthma treatment, Exdensur recently received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for both asthma and CRSwNP indications.
GSK is further evaluating Exdensur’s effectiveness in other inflammatory diseases such as chronic obstructive pulmonary disease (COPD), eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome—all currently undergoing late-stage clinical development.
