PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) said the U.S. Food and Drug Administration has approved Exdensur, a twice-yearly biologic treatment for patients with severe asthma characterized by an eosinophilic phenotype, introducing the first ultra-long-acting option of its kind in the U.S. market.
Exdensur, also known as depemokimab-ulaa, is approved as an add-on maintenance therapy for adults and pediatric patients aged 12 and older. The drug’s approval is based on results from the Phase III SWIFT-1 and SWIFT-2 trials, which demonstrated significant and sustained reductions in asthma exacerbations with just two doses per year when added to standard of care.
In the trials, patients receiving depemokimab experienced a 58 percent reduction in annualized asthma exacerbations in SWIFT-1 and a 48 percent reduction in SWIFT-2 compared with placebo over 52 weeks. The studies also showed fewer severe exacerbations requiring hospitalization or emergency department visits among patients treated with depemokimab. A pooled analysis of both trials found a 72 percent reduction in the annualized rate of clinically significant exacerbations requiring hospital or emergency care compared with placebo.
Across both studies, GSK said depemokimab was well tolerated, with safety outcomes comparable to placebo.
“Physicians in the U.S. 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,” said Kaivan Khavandi, senior vice president and global head of respiratory, immunology and inflammation research and development at GSK. “Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”
Depemokimab was engineered with an extended half-life designed to suppress type 2 inflammation over longer periods, a feature GSK said could reduce treatment burden while improving consistency of care. The company is positioning the therapy as a response to persistent gaps in asthma management, particularly among patients who struggle with frequent injections.
An estimated 2 million Americans live with severe asthma, and roughly half continue to experience frequent exacerbations that can lead to hospitalizations and emergency care. Despite evidence that biologics can help control the disease, GSK said only about 20 percent of eligible U.S. patients currently receive one. Research cited by the company suggests longer dosing intervals could increase adoption, with most physicians viewing reduced injection frequency as beneficial.
“Current biologic treatments for asthma are often underutilized and frequent injections can be inconvenient for many patients and lead to inconsistent use,” said Dr. Geoffrey Chupp, professor of medicine at Yale University. “There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections.”
Patient advocates also welcomed the approval, citing the day-to-day burden of severe asthma. Tonya Winders, president and chief executive officer of the Global Allergy & Airways Patient Platform, said the new option could provide meaningful relief for patients who continue to experience recurring symptoms and attacks.
GSK said depemokimab recently received a positive opinion from Europe’s Committee for Medicinal Products for Human Use, with a regulatory decision expected in the first quarter of 2026. Additional regulatory reviews are underway in several global markets, including China and Japan.
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