BRIEF—GSK's sJNDA for Nucala accepted for review in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for UK Pharma major GSK’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients.

The sJNDA is based on results of the pivotal 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 or eosinophilic chronic rhinosinusitis (ECRS) as well as data from the global Phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.

If approved, mepolizumab would be the first anti-IL-5 biologic for adult patients with inadequately controlled CRSwNP in Japan.

Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged six 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 current treatment.