6th Jan 2026 09:02
(Alliance News) - GSK PLC on Tuesday said depemokimab, sold under the brand name Exdensur, has been approved by Japan's Ministry of Health, Labour and Welfare for severe asthma and chronic rhinosinusitis with nasal polyps.
The London-based pharmaceuticals firm said the approval was based on data from the Swift and Anchor phase III trials which showed sustained efficacy in two doses a year versus placebo.
Results from the Swift trials showed treatment with depemokimab resulted in a significant 58% and 48% reduction in the rate of annualised asthma attacks over 52 weeks versus placebo.
In addition, results from the Anchor trials showed a reduction from baseline in the nasal polyp score at 52 weeks and in the nasal obstruction verbal response scale.
"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," said Kaivan Khavandi, global head, Respiratory, Immunology & Inflammation R&D, GSK.
Exdensur is the first and only ultra-long-acting biologic in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps, GSK noted.
Approval in Japan marks the third regulatory approval for depemokimab, following marketing authorisation from the US Food & Drug Administration and UK's Medicines and Healthcare products Regulatory Agency.
Depemokimab recently received a positive CHMP opinion in the EU and it is currently under regulatory review in other countries, including in China.
Shares in GSK were up 1.4% at 1,845.27 pence each in London on Tuesday morning.
By Jeremy Cutler, Alliance News reporter
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