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Exdensur approved in Japan
GSK plc announced that Exdensur (depemokimab) has been approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps, marking its first approval as an ultra-long-acting biologic in the region. This approval, based on Phase III SWIFT and ANCHOR trials, demonstrated sustained efficacy with twice-yearly dosing, showing significant reductions in asthma exacerbations and improvements in nasal polyp symptoms. The drug's ability to provide sustained suppression of type 2 inflammation with infrequent dosing is expected to set a new standard of care and potentially improve patient outcomes while reducing healthcare system burden. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 6 January 2026, London, UK\n \nExdensur (depemokimab) approved in Japan for severe asthma and chronic rhinosinusitis with nasal polyps\n \n· 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) \n· Approval based on data from the SWIFT and ANCHOR phase III trials showing sustained efficacy in two doses a year versus placebo\n· Patients with severe asthma face frequent exacerbations, hospitalisations and disease progression, requiring an urgent need for novel solutions\n \n \n \nGSK plc (LSE/NYSE: GSK) today announced the approval of Exdensur (depemokimab) by Japan's Ministry of Health, Labour and Welfare (MHLW) as a treatment for bronchial asthma (limited to severe or refractory patients whose asthma symptoms cannot be controlled with existing treatments) and CRSwNP (limited to patients inadequately controlled with standard treatment).\n \nThe 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.1,2\n \nKaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: \"Building on other recent regulatory milestones, the approval of Exdensur in Japan could set a new standard of care for patients with severe asthma or CRSwNP. By delivering sustained suppression of type 2 inflammation in just two doses a year, physicians can now provide an ultra-long-acting option to help protect against asthma exacerbations and the debilitating symptoms of CRSwNP.\"\n \nPatients in Japan living with severe asthma can experience frequent exacerbations and progression of their disease, leading to hospitalisations and increased overall healthcare costs.3-6 In addition, patients with CRSwNP face debilitating daily symptoms and almost half remain uncontrolled.3,7 Depemokimab is a novel therapy that has been developed with ...