GSK PLC (LSE:GSK, NYSE:GSK) said Japan has approved Exdensur (depemokimab) to treat severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps.
The big-cap drugmaker said the authorisation was based on phase III SWIFT and ANCHOR trial data evaluating twice-yearly dosing versus placebo, each on top of standard of care. It added that SWIFT-1 and SWIFT-2 showed significant reductions in asthma exacerbations, while ANCHOR-1 and ANCHOR-2 showed improvements in nasal polyp size and nasal obstruction measures.
Kaivan Khavandi, senior vice president and global head of Respiratory, Immunology & Inflammation R&D at GSK, said: “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.”
GSK said depemokimab was well-tolerated across the trials, with similar rates and severity of side effects to placebo, and described Japan as the third regulatory approval for the medicine after the US and UK.