GSK announces extension of FDA review period for momelotinib

GSK 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. GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review. Momelotinib is not currently approved in any market. About momelotinib 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). 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 About myelofibrosis 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. 1,5,6 GSK in oncology GSK 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. About GSK GSK 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. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include but are not limited to those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, GSK’s Q1 Results for 2023 and any impacts of the COVID-19 pandemic. References [1]Chifotides, HT, Bose, P, Verstovsek, S. Momelotinib: an emerging treatment for myelofibrosis patients with anemia. J Hematol Oncol. 2022;15(7):1-18. [2]Verstovsek S, et al. MOMENTUM: momelotinib vs danazol in patients with myelofibrosis previously treated with JAKi who are symptomatic and anemic. Future Oncol. 2021;17(12):1449-1458. [3]Asshoff M, et al. Momelotinib inhibits ACVR1/ALK2, decreases hepcidin production, and ameliorates anemia of chronic disease in rodents. Blood. 2017;129(13):1823-1830. [4]Oh S, et al. ACVR1/JAK1/JAK2 inhibitor momelotinib reverses transfusion dependency and suppresses hepcidin in myelofibrosis phase 2 trial. Blood Adv. 2020;4(18):4282-4291. [5]Data on file. Sierra Oncology. 2021. [6]Naymagon, L, Mascarenhas, J. Myelofibrosis-Related Anemia: Current and Emerging Therapeutic Strategies. HemaSphere. 2017;1(1):e1. You might also like Media contacts Access GSK's media relations team Media library Search and download images and B-roll video for use in the media. Company We discover, develop and deliver medicines and vaccines to create value for patients and shareholders. Gsk Logo This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our location selector. © 2001-2026 GSK plc. All rights reserved. Trade marks are owned by or licensed to the GSK group of companies. GSK plc. Registered in England and Wales No. 3888792. Registered office: 79 New Oxford Street, London. United Kingdom. WC1A 1DG > Modern Slavery Act Statement 2025 (PDF - 187.7KB) GSK websites Locations selector Social media directory GSKPro for healthcare professionals GSK study register Supplier website ViiV Healthcare Quick links Behind the Science magazine Company Innovation Products Responsibility Investors Media Careers Get in touch Contact us Partnerships Report a possible side effect GSK Speak up Follow us on: Accessibility Digital sustainability Terms of use Cookie policy Privacy notice Sitemap

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