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 March 2026
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: 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
life1-4
●
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 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.
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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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Sarah Clements
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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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Constantin Fest
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+44 (0) 7831 826525
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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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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Sam Piper
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+44 (0) 7824 525779
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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 3126
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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for
2025.
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
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
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: March
19, 2026
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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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