REG - GSK PLC - Extension of FDA review period for momelotinib

GSKAnnouncement

16/06/2023 07:00

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RNS Number : 9216C  GSK PLC  16 June 2023

Issued: 16 June 2023, London UK

 

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  (#_edn1) (, 2  (#_edn2) , 3  (#_edn3) , 4 
(#_edn4) ) 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 
(#_edn5) , 6  (#_edn6) )

 

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.

 

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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,
and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

 

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 1  (#_ednref1) Chifotides, HT, Bose, P, Verstovsek, S. Momelotinib: an
emerging treatment for myelofibrosis patients with anemia. J Hematol Oncol.
2022;15(7):1-18.

 2  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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  (#_ednref5) Data on file. Sierra Oncology. 2021.

 6  (#_ednref6) Naymagon, L, Mascarenhas, J. Myelofibrosis-Related Anemia:
Current and Emerging Therapeutic Strategies. HemaSphere. 2017;1(1):e1.

 

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