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 reduction with two doses per year versus placebo, both plus standard of care.

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Treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma exacerbations (asthma attacks) over 52 weeks from SWIFT-1 and SWIFT-2, respectively.

In a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with depemokimab experienced numerically fewer exacerbations requiring hospitalisation and/or emergency department visits (1% and 4%) compared with placebo (8% and 10%), respectively.

A pre-specified pooled analysis of the two trials showed there was a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospitalisation and/or ED visits over 52 weeks for depemokimab compared with placebo.

Depemokimab recently received marketing authorisation from the U.K.’s Medicines and Healthcare products Regulatory Agency and a positive CHMP opinion in Europe, with an approval decision expected in the first quarter of 2026.

GSK Price Action: GSK shares were up 1.21% at $49.37 during premarket trading on Tuesday. The stock is trading near its 52-week high of $49.39, according to Benzinga Pro data.

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