Human medicines European public assessment report (EPAR): Lynavoy, Linerixibat, Date of authorisation: 22/10/2026, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Introduction

Lynavoy is a medicine used in adults to treat cholestatic pruritus (intense itching due to a build-up of bile) caused by primary biliary cholangitis.

Primary biliary cholangitis is an autoimmune liver disease, a condition in which the immune system (the body’s natural defences) gradually damages the bile ducts in the liver. These ducts carry bile (a fluid that helps the body digest fats) from the liver to the intestines. When the ducts are damaged, bile builds up in the liver, causing damage to liver tissue and leading to symptoms such as itching. 

Primary biliary cholangitis is rare and Lynavoy was designated as an ‘orphan medicine’ (a medicine used in rare diseases) on 12 November 2021. Further information on the orphan designation can be found on the EMA website.

Lynavoy contains the active substance linerixibat.

Lynavoy can only be obtained with a prescription and is available as tablets to be taken by mouth twice daily.

If Lynavoy is taken alongside a bile-acid binding medicine (another medicine used to treat cholestatic pruritus), the two medicines should be taken at least 4 hours apart.

If no benefit is seen after taking Lynavoy every day for 3 months, the doctor should consider a different treatment.

For more information about using Lynavoy, see the package leaflet or contact your doctor or pharmacist.

The active substance in Lynavoy, linerixibat, blocks the action of a protein called ileal bile acid transporter (IBAT) found in the last part of the small intestine (ileum). This protein helps to transport bile acids (a major component of bile) from the gut back to the blood and liver. By blocking IBAT, the medicine causes more bile acids to leave the body in the stools and lowers the amount of bile acids in the blood. This leads to improvements in itching associated with primary biliary cholangitis. Lynavoy also lowers other substances thought to be in involved in itching.

A main study involving 238 adults with primary biliary cholangitis and moderate-to-severe pruritus showed that Lynavoy helps reduce itching associated with the disease. Patients received either Lynavoy or placebo (a dummy treatment) in addition to their usual treatment for primary biliary cholangitis. The study looked at how much itching improved on a scale from 0 to 10.

Over 24 weeks, itching improved more in patients taking Lynavoy than in those taking placebo. The monthly itch score improved by an average of 2.9 points in patients taking Lynavoy, compared with 2.2 points in those taking placebo. Improvements were seen as early as two weeks after starting treatment. Patients taking Lynavoy reported that itching disturbed their sleep less than those taking placebo: the monthly sleep score improved by around 2.8 points in people taking Lynavoy and 2.2 points in those taking placebo. 

In addition, using the Patient Global Impression of Itch Severity (PGI-S) and Change (PGI-C) scales, patients reported greater improvements in itch severity with Lynavoy than with placebo and a larger proportion of patients on Lynavoy indicated that itching was ‘very much improved’. Patients taking placebo were more likely to report no change in their symptoms than those taking Lynavoy.

Studies carried out with Lynavoy are described in more detail in the medicine’s assessment report.

For the full list of side effects and restrictions with Lynavoy, see the package leaflet.

The most common side effects with Lynavoy (which may affect more than 1 in 10 people) are diarrhoea and abdominal (belly) pain.

Itching is a common symptom of primary biliary cholangitis, and at the time of the authorisation of Lynavoy, there was a substantial unmet need for effective treatments for this symptom, particularly for patients with severe itching. Lynavoy was shown to improve itching and to reduce how much itching disturbed patients’ sleep. Although the improvement with Lynavoy was modest, the benefits were seen consistently across the measures used and were greatest in patients whose itching was severe. 

Regarding safety, the side effects are consistent with those known for this type of medicine and are considered manageable.

In reaching its decision, the European Medicines Agency also considered input from a patient and a healthcare professional organisation.

The Agency therefore decided that Lynavoy’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynavoy have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lynavoy are continuously monitored. Suspected side effects reported with Lynavoy are carefully evaluated and any necessary action is taken to protect patients.

Lynavoy received a marketing authorisation valid throughout the EU on 22 October 2022.

Product information

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Product details

Name of medicine

Lynavoy

Active substance

Linerixibat

International non-proprietary name (INN) or common name

Linerixibat

Therapeutic area (MeSH)

• Liver Cirrhosis, Biliary
• Pruritus

Anatomical therapeutic chemical (ATC) code

A05AX

Pharmacotherapeutic group

Bile and liver therapy

Therapeutic indication

Lynavoy is indicated for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).

EMA product number

EMEA/H/C/006241

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Opinion adopted

23/07/2026

Opinion status

Positive

Marketing authorisation issued

22/10/2026

This page was last updated on 27/10/2026