GSK (GSK) said Tuesday that Japan's Ministry of Health, Labour and Welfare has approved Exdensur as a treatment for severe bronchial asthma and chronic rhinosinusitis with nasal polyps.
The approval was based on data from the SWIFT and ANCHOR phase III trials, which showed that treatment with a twice-yearly dose of depemokimab resulted in significant reductions in asthma exacerbations and significant improvements in nasal polyp size and nasal obstruction versus placebo plus standard of care, the company said.
GSK shares were up more than 2% in recent Tuesday premarket activity.
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