FDA Approves Exdensur for Severe Asthma

MONDAY, Dec. 22, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

Exdensur is the first and only long-acting biologic with an extended half-life enabling twice-yearly dosing for patients with severe asthma with an eosinophilic phenotype.

The approval is based on data from the SWIFT-1 and SWIFT-2 phase 3 trials. Results show treatment with Exdensur resulted in a significant 58 and 48 percent reduction in the rate of annualized asthma exacerbations over 52 weeks for SWIFT-1 and SWIFT-2, respectively. Similarly, patients treated with Exdensur experienced numerically fewer exacerbations requiring hospitalization and/or emergency department visits (1 and 4 percent, respectively) versus placebo (8 and 10 percent, respectively). In a prespecified pooled analysis, there was a 72 percent reduction in the annualized rate of clinically significant exacerbations requiring hospitalization or emergency department visits over 52 weeks for Exdensur versus placebo. Exdensur was well tolerated in both trials, with patients experiencing a similar rate and severity of side effects as seen with placebo.

“Physicians in the United States now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year,” Kaivan Khavandi, senior vice president and global head of Respiratory, Immunology & Inflammation Research and Development at GSK, said in a statement. “Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”

Approval of Exdensur was granted to GSK.

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