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 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 2 June 2025, London UK
Linerixibat New Drug Application (NDA) accepted for review by the
US FDA for cholestatic pruritus in patients with primary biliary
cholangitis (PBC)
● If approved, linerixibat could address high unmet
medical need of patients living with cholestatic pruritus
(relentless itch) and related sleep
interference
● Application based on data from positive GLISTEN
phase III trial
● 24 March 2026 assigned as Prescription Drug User
Fee Act (PDUFA) goal date for FDA decision
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has accepted for review the NDA for
linerixibat, an investigational targeted inhibitor of the ileal
bile acid transporter (IBAT), for the treatment of cholestatic
pruritus in patients with PBC, a rare autoimmune liver disease. The
Prescription Drug User Fee Act (PDUFA) goal date is 24 March
2026.
Kaivan Khavandi, SVP, Global Head, Respiratory,
Immunology & Inflammation R&D, GSK,
said: "The
FDA's acceptance of this file is an important milestone in the
development of linerixibat. We believe that linerixibat has the
potential to make a difference in the lives of patients living with
relentless itch associated with PBC and its related sleep
interference. These are debilitating symptoms which currently have
very limited treatment options."
The application is based on positive data from the GLISTEN phase
III trial, presented in May at the European Association for the
Study of the Liver (EASL) Congress. GLISTEN met both primary and
key secondary endpoints demonstrating a rapid, significant and
sustained improvement in cholestatic pruritus and itch-related
sleep interference versus placebo. The safety profile of
linerixibat was consistent with previous studies and the mechanism
of IBAT inhibition.
Linerixibat is currently not approved anywhere in the
world.
About cholestatic pruritus in PBC
In PBC, a cholestatic liver disease, bile flow from the liver is
disrupted. The resulting excess bile acids in circulation are
thought to play a causal role in cholestatic pruritus, an internal
itch that cannot be relieved by scratching. Pruritus can occur at
any stage of PBC disease or biochemical control, and is experienced
in varying degrees of severity by up to 90% of people living with
PBC.1 The
first line treatment for PBC controls disease in approximately 70%
of patients, but does not reduce the severity or impact of the
pruritus.2,3 Cholestatic
pruritus is a serious condition that can be debilitating, with
patients experiencing sleep disturbance, fatigue, impaired quality
of life and even sometimes requiring liver transplantation in the
absence of liver failure.3,4
About linerixibat (GSK2330672)
Linerixibat is an IBAT inhibitor, a targeted oral agent with
potential to treat cholestatic pruritus (itch) associated with the
rare autoimmune liver disease known as PBC. By inhibiting bile acid
re-uptake, linerixibat reduces multiple mediators of pruritus in
circulation. The US Food and Drug Administration and the European
Medicines Agency have granted orphan drug designation for
linerixibat in the treatment of cholestatic pruritus in patients
with PBC.
About the GLISTEN trial
GLISTEN is a double-blind, randomised, placebo-controlled, phase
III trial (NCT04950127; GSK study 212620) conducted in 238 PBC
patients with cholestatic pruritus initially enrolled equally into
active and placebo arms (n=119 each). The primary analysis
evaluated the efficacy and safety of linerixibat compared with
placebo. Participants with moderate to severe itch were enrolled.
Participants initially received either linerixibat or placebo and
had the potential to cross over in a part B of the trial. Primary
and secondary outcome measures were assessed using a 0-10 numerical
rating scale for worst itch and itch-related sleep interference.
Stable use of guideline suggested anti-itch therapy was permitted.
The trial was the first truly global PBC study completed in 19
countries including the Americas, Europe, China and
Japan.
About GSK research in hepatology
GSK is currently investigating multiple potential treatments for
patients with liver disease. In addition to PBC, we are also
investigating potential treatments for chronic hepatitis B,
alcohol-related liver disease (ALD), and metabolic
dysfunction-associated steatohepatitis (MASH).
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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Investor
Relations:
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Fest
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James
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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1.
Gungabissoon U, et al. BMJ
Open Gastroenterol 2024; 11(1)
2.
Carbone M, et al. Lancet
Gastroenterol Hepatol. 2018 Jul
13;3(9):626-634
3.
Smith 2025; Hepatol
Commun.9(3):e0635
4. Lindor
KD, et al. Hepatology. 2019;69(1):394-419
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
02, 2025
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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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