Nucala (mepolizumab) approved in Japan for treatment of adults with chronic rhinosinusitis with nasal polyps – GSK

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients,limited to those who are inadequately controlled with standard treatment.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, at GSK said: “The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids.”

CRSwNP is a chronic condition that affects 1% to 4% of the general population, of whom 40% have uncontrolled disease. People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge, which can significantly affect their emotional and physical well-being. In Japan, an estimated 2 million people suffer from chronic rhinosinusitis, of which about 200,000 are subject to surgery due to nasal polyps.

CRSwNP is caused by chronic inflammation of the nasal lining that can cause soft tissue growth, known as nasal polyps, that develop in the sinuses and nasal cavity. Over 80% of patients with CRSwNP have type 2 inflammation, which is associated with more severe disease and nasal polyp recurrence. IL-5 is a key cytokine driving this type 2 inflammation and is present at high levels in nasal polyp tissue. Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow.

The approval is based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.