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GSK reports EMA accepts marketing authorization application for momelotinib

GSK plc announced that the European Medicines Agency, or EMA, validated the marketing authorization application for momelotinib, a potential new oral treatment for myelofibrosis. Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signaling pathways: Janus kinase 1, and JAK2 and activin A receptor type I, which could address the significant medical needs of myelofibrosis patients with anaemia. The MAA is based on results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, the company stated.

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