The Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted GSK’s supplementary new drug application (sJNDA) for Nucala (mepolizumab), to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adults, for review.
Nucala is a monoclonal antibody designed to target and bind to interleukin-5 (IL-5), a cytokine that assists in the maturation and activation of eosinophils.
The sJNDA was submitted based on data from the pivotal Phase III MERIT study, which assessed the safety and efficacy of mepolizumab for more than 52 weeks in Russian, Chinese and Japanese patients with inadequately controlled CRSwNP or eosinophilic chronic rhinosinusitis.
It is also based on data from the global Phase III SYNAPSE study, which evaluated the effect of mepolizumab against placebo in more than 400 patients with CRSwNP.
If mepolizumab is approved, it is expected to become the first anti-IL-5 biologic for adults with inadequately controlled CRSwNP in Japan.
In Japan, mepolizumab already received approval to treat bronchial asthma in children aged six years or above and in adults with refractory asthma whose symptoms could not be controlled adequately with standard treatment.
Furthermore, it was approved to treat adult patients with eosinophilic granulomatosis with polyangiitis. They have an inadequate response to the current treatment.
In 2015, Nucala was first approved to treat eosinophilic asthma in the US.
Mepolizumab has been developed to treat several IL-5-mediated diseases detected by increased eosinophil counts. It was studied in more than 4,000 patients in 41 clinical trials across various indications.
