Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

Core Insights - GSK plc announced FDA approval for Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older [1][9]. Clinical Trial Results - The FDA approval is based on the SWIFT-1 and SWIFT-2 phase III trials, where depemokimab showed a 58% and 48% reduction in annualized asthma exacerbations compared to placebo over 52 weeks [2]. - A pooled analysis indicated a 72% reduction in clinically significant exacerbations requiring hospitalization or emergency department visits for depemokimab compared to placebo [3]. Treatment Benefits - Depemokimab offers sustained protection from exacerbations with only two doses per year, potentially redefining patient care for severe asthma [4]. - The treatment is well-tolerated, with side effects similar to those of placebo [3]. Market Context - Approximately 2 million Americans suffer from severe asthma, with half experiencing frequent exacerbations that lead to increased healthcare costs [5]. - Currently, only 20% of eligible patients in the US receive biologics, indicating a significant unmet need in the market [5]. Future Prospects - Depemokimab has received a positive opinion from the CHMP in Europe, with an approval decision expected in Q1 2026, and is under review in other regions including China and Japan [7]. - GSK is expanding its pipeline for depemokimab to include other diseases with type 2 inflammation, such as chronic rhinosinusitis and chronic obstructive pulmonary disease (COPD) [18].