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GSK PLC on Monday reported regulatory progress for momelotinib, as Japan’s Ministry of Health, Labour & Welfare accepted a review for the blood cancer-focused drug. The London-based pharmaceutical maker said the Japanese regulator 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. Momelotinib is an inhibitor of Janus kinases JAK1 and JAK2, which are proteins that signal a certain form of cytokines, which are small proteins that play an important role in cell signaling. Myelofibrosis is a blood cancer that can lead to splenomegaly; constitutional symptoms such as fatigue, night sweats, and bone pain; and severely low blood counts, including anaemia and thrombocytopenia. Patients who depend on transfusions have a poor prognosis and shortened survival. The new drug application is based on data from the pivotal phase III trials Simplify-1 and Momentum, GSK said. Momelotinib is not currently approved in any market. GSK shares rose 1.7% to 1,468.20 pence each on Monday morning in London. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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