REG - GSK PLC - Lynavoy (linerixibat) approved by US FDA

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RNS Number : 3290X  GSK PLC  19 March 2026

Issued: 19 March 2026, London UK

 

Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in
patients with primary biliary cholangitis (PBC)

 

·   Lynavoy, an ileal bile acid transporter (IBAT) inhibitor, is the first
medicine approved in the US for the treatment of cholestatic pruritus in
patients with PBC

·   Up to 89% of people living with PBC experience cholestatic pruritus, an
internal itch with a debilitating impact on quality of life(1-4)

·   Approval based on the positive GLISTEN phase III trial with regulatory
reviews underway in the EU, UK, Canada and China

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of
cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid
transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is
the first medicine approved in the US for this indication.(5)

 

GSK previously announced on 9 March
(https://www.gsk.com/en-gb/media/press-releases/gsk-and-alfasigma-announce-agreement/)
a licence agreement under which Alfasigma S.p.A. will acquire worldwide
exclusive rights to develop, manufacture and commercialise linerixibat. This
transaction is ongoing and is subject to customary conditions, including
applicable regulatory agency clearances such as under the Hart-Scott-Rodino
Act in the US.

 

Cholestatic pruritus is an internal itch experienced by up to 89% of people
living with PBC, a rare autoimmune disease that can lead to liver
failure.(1-4) It 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.(3,6,7)

 

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation,
and Head of GSK Translational & Development Sciences, GSK, said: "The
approval of Lynavoy in the US gives patients a much needed treatment option
that offers rapid, significant and sustained improvement in the debilitating
effects of itch caused by PBC. For many patients, cholestatic pruritus remains
a persistent, poorly addressed condition. This is the first liver medicine
from our pipeline to receive approval, underscoring our commitment to
developing meaningful innovation across the spectrum of liver disease."

 

Christopher Bowlus M.D., Lena Valente Professor and Chief of Gastroenterology
and Hepatology, University of California Davis, said: "The approval of
linerixibat represents an important opportunity to improve the lives of people
with PBC and who struggle with uncontrolled and often debilitating pruritus.
The impact of itch on people living with PBC can be profound and treatment
options have until now been limited. The FDA's decision marks a major
milestone in PBC pruritus care that addresses a critical area of unmet need."

 

Carol Roberts, President, The PBCers Organization, said: "Cholestatic pruritus
has been underestimated and overlooked for far too long, despite its
significant impact on people living with PBC. Seeing a treatment specifically
developed for chronic itch finally reach patients is a significant step
forward and offers hope for those in need."

 

The approval is based on data from the global GLISTEN phase III trial which
met both primary and key secondary endpoints, demonstrating significant, rapid
(at week two) and sustained (over 24 weeks) improvements in cholestatic
pruritus and itch-related sleep interference versus placebo.(8)

 

Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan,
and priority review in China, for the treatment of cholestatic pruritus in
patients with PBC. Marketing applications for linerixibat are ongoing in the
EU, UK, Canada and China.

 

About cholestatic pruritus in PBC

In PBC, a rare 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.(9) It 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.(3,6,7)

 

About Lynavoy (linerixibat)

Linerixibat is an IBAT inhibitor, a targeted oral agent to treat cholestatic
pruritus (itch) associated with the rare autoimmune liver disease PBC.(8) By
inhibiting bile acid re-uptake, linerixibat reduces multiple mediators of
pruritus in circulation.(5)

 

About the GLISTEN trial

GLISTEN is a double-blind, randomised, placebo-controlled, phase III trial.
The primary and key secondary endpoints of the study were met, demonstrating
significant, rapid (at week two), and sustained (over 24 weeks) improvements
in cholestatic pruritus (p<=0.001) and itch-related sleep interference
(p=0.024) versus placebo. The primary endpoint of change from baseline in
monthly itch score showed linerixibat (n=119) significantly improved itch
versus placebo (n=119) over 24-weeks, as measured on a 0-10 numerical rating
scale (NRS) for the worst itch (WI-NRS) (least squares  LS  mean difference
[95% CI]: -0.72 [-1.15, -0.28], p=0.001). The safety profile of linerixibat
was consistent with previous studies and the mechanism of IBAT inhibition. The
most frequently reported adverse events were diarrhoea (61%) and abdominal
pain (18%), both of which were mostly mild to moderate. Treatment
discontinuation due to diarrhoea was in 4% of patients versus <1% in
placebo, and abdominal pain in 4% versus none in placebo.(8)

 

About GSK research in hepatology

GSK is extending its expertise in inflammation to develop a next wave
of innovation for the millions of people affected by chronic and
life-threatening fibro-inflammatory liver conditions. Harnessing the science
of the immune system and advanced technologies, GSK is committed to
advancing its hepatology pipeline with potential therapies for chronic
hepatitis B and steatotic liver disease (SLD), including metabolic
dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver
disease (ALD).

 

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 www.gsk.com
(https://www.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 2025.

 

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References

1.     Hegade VS, et al. Clin Gastroenterol Hepatol. 2019;17(7):1379-87.
doi: 10.1016/j.cgh.2018.12.00

2.     Mayo MJ, et al. Dig Dis Sci. 2023;68:995-1005. doi:
10.1007/s10620-022-07581-x

3.     de Veer RC, et al. Hepatol Res. 2023;53:401-8. doi:
10.1111/hepr.13880

4.     Gungabissoon U, et al. BMJ Open Gastroenterol. 2024;11;e001287.
doi: 10.1136/bmjgast-2023-001287

5.     Kremer A, et al. Hepatol. 2025; 82(S1); S204. doi:
10.1097/HEP.0000000000001493

6.     Smith HT, et al. Hepatol Commun. 2025; 9(3):e0635. doi:
10.1097/HC9.0000000000000635

7.     Lindor KD, et al. Hepatol. 2019;69(1):394-419. doi:
10.1002/hep.30145

8.     Hirschfield GM, et al. Lancet Gastroenterol Hepatol. 2026; 11(1):
22-33. doi: 10.1016/S2468-1253(25)00192-X

9.     Düll MM, Kremer AE. Clin Liver Dis. 2022; 26(4):727-45. doi:
10.1016/j.cld.2022.06.009

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