The Medicines and Healthcare products Regulatory Agency (MHRA)
has today 1 May 2026, approved Linerixibat (Lynavoy) for use
to treat an itch in adults with primary biliary cholangitis
(PBC).
PBC is a condition where bile ducts in the liver become damaged,
leading to a build-up of bile acids in the blood. This
build-up is thought to cause itching. Linerixibat helps
to reduce the build-up of substances, including bile acids, in
the body and so reduce itching.
Linerixibat is administered via an orally
ingested film-coated tablet. The recommended dose is one
tablet taken twice a day.
A global Phase 3 clinical trial, Glisten, evaluated the
safety and effectiveness of linerixibat for treating
itching in patients with PBC. In the study, 238 patients were
randomly assigned to receive either linerixibat 40 mg
twice daily or a placebo for 24 weeks.
The results showed that linerixibat significantly
reduced itching and improved sleep disruption caused by itching.
The study's main measure, the Monthly Itch Score, showed a
statistically significant improvement in patients treated
with linerixibat compared with those given
placebo.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
said:
“The approval of linerixibat provides a new treatment
option for adults with primary biliary cholangitis who
experience itching associated with their condition.
“As with all medicines, we will continue to closely monitor the
safety and effectiveness of linerixibat as it is used
more widely.”
For the full list of all side effects reported with this
medicine, see Section 4 of the PIL or the SmPC available on the
MHRA website.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their doctor, pharmacist or
nurse and report it to the Yellow Card scheme, either through the
website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
