a9217c
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June 2023
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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],[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.
GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Dan
Smith
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: June
16, 2023
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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