USFDA extends review period of GSK Momelotinib by three months
London: GSK plc has 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.
"GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review," the company stated.
Momelotinib is not currently approved in any market.
Momelotinib 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). Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly. Additionally, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.
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. Myelofibrosis affects approximately 25,000 patients in the US.
GSK’s pipeline is focused on immuno-oncology, tumour cell targeting therapies and synthetic lethality.
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