The Medicines and Healthcare products Regulatory Agency (MHRA) has approved linerixibat (brand name Lynavoy) for the treatment of cholestatic pruritus (itch) in adults living with Primary Biliary Cholangitis (PBC). This follows recent approval by the U.S. Food and Drug Administration (FDA), marking an important milestone for the global PBC community.

For many people living with PBC, itch is far more than an inconvenience. It can be relentless, exhausting, isolating, and have a significant impact on sleep, mental wellbeing, daily activities, work, and overall quality of life. For some, it becomes one of the most difficult symptoms of the condition to manage.

Linerixibat is the first medicine specifically approved in both the UK and US to target cholestatic itch associated with PBC. It works by reducing the build-up of bile acids and other substances believed to contribute to itching. The treatment is taken orally as a tablet twice daily.

At the PBC Foundation, we know just how serious and life-changing PBC itch can be. Over many years, members of our community have spoken powerfully about the physical and emotional toll it takes, and we have consistently highlighted the urgent unmet need for more effective treatment options.

“Please do not underestimate the impact of PBC itch. It can be exhausting, isolating, and completely overwhelming at times. Having experienced severe itch myself, I know how desperately people have needed more effective treatment options. Seeing this news was incredibly emotional for me personally, because I know what this symptom takes from people and how long so many in our community have waited for progress in this area. This approval is an important moment and offers real hope for the future.”
— Mo Christie

This approval represents an important step forward and offers new hope for people whose lives are affected by cholestatic itch.

What Happens Next?

Following approval by the Medicines and Healthcare products Regulatory Agency (MHRA), linerixibat is now licensed for use in the UK for the treatment of cholestatic itch in adults living with PBC.

The next stage will involve health technology appraisal processes, including review by the National Institute for Health and Care Excellence (NICE) in England, which considers both effectiveness and cost when determining whether a treatment should be routinely available on the NHS.

Separate assessment processes also take place in other parts of the UK, including through the Scottish Medicines Consortium (SMC) in Scotland.

These appraisal processes help determine how and when patients may be able to access the treatment through NHS services. Further information on availability and access pathways is expected in due course.

You can follow the NICE appraisal process here:
NICE linerixibat appraisal page You can also read the full MHRA announcement here:
MHRA approval announcement for linerixibat (Lynavoy)