The Medicines and Healthcare products Regulatory Agency (MHRA) recently 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.

Julian Beach, Interim Executive Director, Healthcare Quality and Access, 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.”