REG - GSK PLC - Linerixibat file accepted for review by US FDA

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RNS Number : 8976K  GSK PLC  02 June 2025

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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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.

 

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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

 

 

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