GSK's Severe Asthma Treatment Wins US FDA Approval

02:31 AM EST, 12/17/2025 (MT Newswires) -- The US Food and Drug Administration cleared GSK's (GSK.L) Exdensur as an add-on maintenance treatment for severe asthma, with an eosinophilic phenotype in adult and paediatric patients aged 12 years and above. The approval was based on the pharmaceutical company's Swift-1 and Swift-2 phase 3 clinical trials, which showed a 58% and 48% decrease in annual asthma attacks for patients treated with Exdensur, or depemokimab-ulaa, compared with placebo, respectively, according to a Wednesday release. The studies also demonstrated that patients experienced lower exacerbations that required hospitalization when compared to placebo. GSK noted that Exdensur is under review in China and Japan, with an approval decision from the UK's Medicines and Healthcare products Regulatory Agency slated in the first quarter of 2026.