Japan's Drug Regulator Approves GSK's Exdensur (depemokimab) for Severe Bronchial Asthma and Chronic Rhinosinusitis With Nasal Polyps

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  • Exdensur is the first and only ultra-long-acting biologic in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • Approval based on data from the SWIFT and ANCHOR phase III trials showing sustained efficacy in two doses a year versus placebo.
  • The MHLW approval was based on data from the SWIFT and ANCHOR phase III trials, which demonstrated the sustained efficacy of a twice-yearly dose of depemokimab versus placebo, both plus standard of care. In SWIFT-1 and SWIFT-2, treatment with depemokimab resulted in significant reductions in asthma exacerbations. 
  • Additionally, ANCHOR-1 and ANCHOR-2 showed significant improvements in nasal polyp size and nasal obstruction, two key measures of disease severity.
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