US FDA Approves GSK's Depemokimab for Severe Asthma

The US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa), a new treatment from GSK plc for severe asthma. The drug is indicated as an add-on maintenance therapy for adult and adolescent patients aged 12 and older who have severe asthma characterized by an eosinophilic phenotype.

Exdensur's approval marks the introduction of the first biologic therapy for this patient group that allows for twice-yearly administration. Clinical trials, SWIFT-1 and SWIFT-2, formed the basis for the FDA's decision. These studies demonstrated that depemokimab significantly reduced the rate of asthma exacerbations, commonly known as asthma attacks, over a 52-week period compared to placebo when used in addition to standard care. Specific reductions reported were 58% in SWIFT-1 and 48% in SWIFT-2.

Further analysis from the trials indicated a reduction in exacerbations requiring hospitalization or emergency department visits. A pooled analysis showed a 72% reduction in the annualised rate of clinically significant exacerbations needing such care for patients receiving depemokimab compared to those on placebo. The drug was generally well-tolerated, with side effect rates similar to the placebo group.

Approximately 2 million Americans live with severe asthma, and a significant portion continue to experience frequent exacerbations despite current treatments. GSK highlighted that depemokimab's extended half-life allows for sustained suppression of type 2 inflammation contributing to the disease, potentially improving patient outcomes and reducing healthcare system burden. Regulatory reviews for depemokimab are also ongoing in Europe, China, and Japan.