Japan Approves Exdensur (depemokimab) for Severe Asthma and Nasal Polyps
GSK plc has announced that Japan’s Ministry of Health, Labour and Welfare has approved Exdensur (depemokimab) for the treatment of bronchial asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The approval applies to patients with severe or refractory asthma whose symptoms remain uncontrolled despite existing therapies, as well as CRSwNP patients who are inadequately controlled with standard treatment.
The MHLW decision was supported by data from the Phase III SWIFT and ANCHOR clinical trial programmes. These studies demonstrated that depemokimab, administered twice yearly in addition to standard of care, delivered sustained efficacy compared with placebo. In the SWIFT-1 and SWIFT-2 trials, depemokimab significantly reduced asthma exacerbations, while the ANCHOR-1 and ANCHOR-2 trials showed meaningful improvements in nasal polyp size and nasal obstruction, two key indicators of CRSwNP severity.
Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK, commented that the approval represents a potential shift in treatment standards for patients with severe asthma and CRSwNP in Japan. He highlighted that the ultra-long-acting profile of depemokimab, requiring only two doses per year, enables sustained suppression of type 2 inflammation and offers physicians a new option to help reduce asthma exacerbations and alleviate the chronic symptoms associated with CRSwNP.
In Japan, patients with severe asthma often experience frequent exacerbations that can lead to disease progression, hospitalisations, and increased healthcare costs. Similarly, individuals with CRSwNP face persistent, debilitating symptoms, with nearly half remaining uncontrolled on current therapies. Depemokimab has been engineered with an extended half-life, allowing for long-term control of disease-driving type 2 inflammation through twice-yearly dosing, which may improve patient outcomes while easing the burden on healthcare systems.
Results from the SWIFT trials showed that depemokimab reduced annualised asthma exacerbation rates by 58% in SWIFT-1 and 48% in SWIFT-2 over a 52-week period compared with placebo. Annual exacerbation rates were notably lower in patients treated with depemokimab across both studies.
The ANCHOR trials further demonstrated significant reductions in nasal polyp scores at 52 weeks, along with improvements in nasal obstruction severity during weeks 49 to 52, confirming the therapy’s effectiveness in managing CRSwNP symptoms.
Across all studies, depemokimab was generally well tolerated, with a safety profile comparable to placebo and no new safety concerns identified.
The approval in Japan represents the third regulatory authorisation for depemokimab, following approvals from the U.S. Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The therapy has also received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is currently under regulatory review in additional markets, including China.
