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Dec 17, 2025 12:00 PM

FDA Approves GSK's Drug, Targets Severe Asthma With Two Doses Per Year

On Tuesday, the US Food and Drug Administration (FDA) approved GSK plc’s (NYSE:GSK) Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in patients aged 12 years and older.

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The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase 3 trials.

Trial Data

In these studies, depemokimab demonstrated sustained exacerbation ...