FDA clears GSK’s twice‑yearly asthma drug – dosing cut to two injections a year

The FDA approved GSK’s depemokimab (brand name Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval follows positive SWIFT‑1 and SWIFT‑2 late‑stage data that showed reductions in exacerbations and hospitalizations versus placebo and positions Exdensur as the first ultra‑long‑acting biologic with a twice‑yearly dosing schedule. GSK highlighted the dosing convenience as a potential adherence advantage compared with existing biologics while noting the crowded Type‑2 inflammation market that includes drugs from AstraZeneca, Sanofi, Amgen and others. Clinicians and payers will focus on real‑world uptake and whether less frequent dosing translates into better continuity of care and outcomes.