(Sharecast News) – Japanese regulators are reviewing a new drug application for GSK’s Nucala treatment to be used for the treatment of form of adult sinusitis, the biopharma giant announced on Friday.
The drug, otherwise known as mepolizumab, is already used in Japan to treat bronchial asthma and a rare form of vasculitis, but GSK’s new application is hoped to see it approved as a treatment for chronic rhinosinusitis with nasal polyps.
It would be the first treatment of its kind in the country, GSK said, and the Japanese Ministry of Health, Labour and Welfare has now accepted the regulatory submission for review.
The application is based on the results of a recent clinical trial, which showed that “the efficacy and safety of mepolizumab in the Japanese population were consistent with results from global trials”.
GSK said that chronic rhinosinusitis with nasal polyps affects 2-4% of the general population, who can experience problems such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge.
Around 2m people in Japan have chronic sinusitis, 10% of which are subject to surgery due to nasal polyps.
