New tablet approved to treat biliary tract disease-related itch

Key Summary

• MHRA gives green light to Linerixibat to treat severe itching in PBC patients.
• Successfully proven to reduce itch and improve sleep in clinical trials.
• Patients are urged to seek immediate medical help incase of side-effects.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved GlaxoSmithKline‘s Linerixibat (Lynavoy) tablets to treat the itching caused by primary biliary cholangitis (PBC) in adults.

PBC develops when the bile ducts in the liver gets damaged, causing the bile acids to build-up in the blood. This build-up causes itching in the patients.

The orally ingested film-coated twice-a-day pill, Linerixibat decreases this build-up in the blood and calms the itching.

The tablet had successfully passed Glisten, a global Phase 3 clinical trial where 238 patients were given Linerixibat 40mg tablet or a placebo for 24 weeks.

The Monthly Itch Score or the outcome showed that the patients who consumed the tablets showed significant improvement in their condition, as well as reduced sleep disruption.

“As with all medicines, we will continue to closely monitor the safety and effectiveness of Linerixibat as it is used more widely,” commented Julian Beach, interim executive director of Healthcare Quality and Access at MHRA.

However, Linerixibat also has certain side-effects which can be learnt from Section 4 of PIL or the SmPC available on the MHRA website.

Patients who experience any form adverse reaction from the drug must immediately seek medical help and report the incident via the MHRA Yellow Card Scheme.