GSK plc announced that the Ministry of Health, Labour and Welfare, or MHLW, Japan, has accepted for review a new drug application for momelotinib, a potential new medicine with a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with anaemia. The NDA is based on data from the pivotal phase III trials SIMPLIFY-1 and MOMENTUM. Momelotinib is not currently approved in any market, the company noted.
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