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Extension of FDA review period for momelotinib
Extension of FDA review period for momelotinib.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 16 June 2023, London UK\n \nGSK announces extension of FDA review period for momelotinib\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.\n \nGSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.\n \nMomelotinib is not currently approved in any market.\n \nAbout momelotinib\nMomelotinib has a novel mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).[1],[2],[3],[4] Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.1,2,4 Additionally, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.1,2,3,4\n \nAbout myelofibrosis\nMyelofibrosis 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. Myelofibrosis affects approximately 25,000 patients in the US.1,[5],[6]\n \nGSK in oncology\nGSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, and antibody-drug conjugates, either alone or in combination.\n \nAbout GSK\nGSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.\n \n\n\n\nGSK enquiries\n\n\n\n\n\n\n\n\n\n\n\n\n\nMedia:\n\n\nTim Foley\n\n\n+44 (0) 20 8047 5502\n\n\n(London)\n\n\n\n\n\n\n\nDan Smith\n\n\n+44 (0) 20 8047 5502\n\n\n(London)\n\n\n\n\n\n\n\nKathleen Quinn\n\n\n+1 202 603 5003\n\n\n(Washington DC)\n\n\n\n\n\n\n\nLyndsay Meyer\n\n\n+1 202 302 4595\n\n\n(Washington DC)\n\n\n\n\n\n\n\n\n\n\n \n\n\n\n\n\n\...