LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.
The company noted that Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype.
Depemokimab recently received a positive CHMP opinion in Europe, with an approval decision expected in the first quarter of 2026. Regulatory submissions are also under review across the globe, including in China and Japan.
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