GSK Nucala approved in Japan for treatment of adults with chronic rhinosinusitis with 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.

Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged 6 years or older and in adults with refractory asthma whose symptoms are inadequately controlled with standard treatment, and also for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) inadequately responding to the standard treatment.