GSK :EMA Accepts Marketing Authorization Application For Momelotinib For Rare Blood Cancer Treatment

GSK plc (GSK.L,GSK) said Friday that the European Medicines Agency has accepted the marketing authorization application for momelotinib for the treatment of myelofibrosis.

The application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints.

A Committee for Medicinal Products for Human Use (CHMP) regulatory action is anticipated by year-end 2023, and a New Drug Application for momelotinib is currently under regulatory review with the US Food and Drug Administration with a Prescription Drug User Fee Act action date of 16 June 2023.

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anaemia.

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