The FDA cleared GSK’s depemokimab (Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The agency’s approval follows positive SWIFT‑1 and SWIFT‑2 data showing reductions in exacerbations and hospitalizations versus placebo, and aligns with a recent CHMP recommendation in Europe. GSK positions the ultra‑long‑acting IL‑5 inhibitor as a differentiated dosing option with two doses per year. GSK said the label was supported by two late‑stage trials and expects the drug to address unmet adherence issues tied to frequent biologic dosing schedules. The company will market the product amid a crowded Type‑2 inflammatory biologic landscape that includes competitors from Sanofi/Regeneron and AstraZeneca. Clinicians will watch real‑world uptake, given historically low penetration of biologics among eligible severe asthma patients.