GSK regulatory submission accepted for review by Japanese regulator for Nucala use in adults with chronic rhinosinusitis with nasal polyps
London: GSK plc has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for 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.
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