GSK’s Nucala approved by Japan’s MHLW for treatment of CRSwNP

GSK announced that Japan’s Ministry of Health, Labour and Welfare, MHLW, has approved Nucala, a monoclonal antibody that targets interleukin-5, for the treatment of chronic rhinosinusitis with nasal polyps, CRSwNP, in adult patients, limited to those who are inadequately controlled with standard treatment. 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.