GSK plc announced that the Japanese Ministry of Health, Labour and Welfare has accepted for review a supplementary new drug application, or sJNDA, for Nucala, a monoclonal antibody that targets interleukin-5, as a treatment for chronic rhinosinusitis with nasal polyps in adult patients. “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 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 current treatment,” GSK stated.
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