The FDA has approved GSK’s Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients ages 12 and older.
The approval is based on data from the drugmaker’s SWIFT-1 and SWIFT-2 trials, which showed a 58% and 48% reduction in annualized asthma exacerbations, respectively, compared to placebo, according to a Dec. 16 news release from GSK. A pooled analysis also found a 72% reduction in exacerbations requiring hospitalization or emergency department visits.
Depemokimab, a twice-yearly treatment, has an extended half-life for “sustained suppression of disease-driving type 2 inflammation,” potentially reducing burden on health systems, according to the release.
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