Global pharma powerhouse GSK has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Exdensur (depemokimab) for the treatment of severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in patients inadequately controlled with standard therapies.

 

The approval follows robust data from the SWIFT and ANCHOR Phase III trials, which showed that a twice-yearly dose of depemokimab provided sustained improvements compared with placebo, both alongside standard care. In the SWIFT trials, patients saw significant reductions in asthma exacerbations, while ANCHOR trials demonstrated marked improvements in nasal polyp size and nasal obstruction—key measures of disease severity.

 

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D at 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.”

 

Severe asthma in Japan is associated with frequent exacerbations and disease progression, often leading to hospitalization and rising healthcare costs. CRSwNP similarly impacts daily life, with nearly half of patients remaining uncontrolled despite standard therapy. 

 

Depemokimab’s extended half-life allows for sustained suppression of disease-driving type 2 inflammation with just two annual doses, offering potential improvements in patient outcomes and reduced health system burden.

 

The SWIFT trials reported a 58% reduction in asthma exacerbations in SWIFT-1 and 48% reduction in SWIFT-2 over 52 weeks, with rates dropping from 1.11 to 0.46 in SWIFT-1 and 1.08 to 0.56 in SWIFT-2.

 

In the ANCHOR trials, patients experienced improvements in nasal polyp score and nasal obstruction: ANCHOR-1 showed a -0.7 reduction in nasal polyp score and ANCHOR-2 a -0.6 reduction, alongside meaningful improvements in nasal obstruction verbal response scales.

 

Depemokimab was generally well-tolerated, with side effects comparable to placebo.