In a milestone for respiratory medicine, GSK plc announced today that the U.S. Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype.
The approval introduces the first and only “ultra-long-acting” biologic for asthma, featuring a dosing schedule of just two injections per year. This marks a significant shift from current biologic therapies, which typically require administration every four to eight weeks.
A New Standard for Long-Term Protection
Severe asthma affects approximately 2 million Americans, many of whom struggle with frequent “attacks” or exacerbations despite using high-dose inhalers. Exdensur is designed to target IL-5, a key protein responsible for type 2 inflammation and the recruitment of eosinophils—white blood cells that drive airway swelling and damage.
Clinical Breakthrough: The SWIFT Trials
The FDA’s decision was supported by results from the SWIFT-1 and SWIFT-2 Phase III trials, which were recently published in the New England Journal of Medicine. The studies followed patients over 52 weeks and demonstrated:
- Significant Reduction in Attacks: Patients receiving Exdensur saw a 58% and 48% reduction in annual asthma exacerbations compared to the placebo group.
- Emergency Prevention: A pooled analysis showed a 72% reduction in exacerbations requiring hospitalization or emergency department visits.
- Safety Profile: The drug was well-tolerated, with side effects comparable to those seen in the placebo group.
Global Rollout
The approval in the U.S. follows a recent marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory reviews are currently underway in Europe, China, and Japan, with a European decision expected in early 2026.
Beyond asthma, GSK is investigating depemokimab for other conditions driven by type 2 inflammation, including chronic rhinosinusitis with nasal polyps (CRSwNP) and COPD.
Exdensur is indicated for adult and pediatric patients aged 12 years and older. Patients are encouraged to consult their healthcare provider to see if a twice-yearly biologic is appropriate for their specific asthma phenotype.
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