A new oral treatment for the severe itching that often disrupts sleep and quality of life in primary biliary cholangitis (PBC) could soon reach patients, after European regulators backed Lynavoy (linerixibat, GlaxoSmithKline).

At its July 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use recommended granting marketing authorization for Lynavoy for the treatment of cholestatic pruritus in adults with PBC.

Lynavoy already holds orphan medicine designation in the EU, which was granted during development. EMA will now assess whether that orphan status can be maintained in light of the positive opinion.

About PBC Pruritus and the New Treatment 

Cholestatic pruritus is a major burden for patients with PBC, causing intense, generalized itching that is rarely relieved by scratching and significantly disrupts sleep and overall quality of life. 

Linerixibat is an ileal bile acid transporter inhibitor that reduces intestinal bile acid reabsorption, increasing bile acid excretion from the gut and thereby lowering circulating bile acids believed to contribute to cholestatic pruritus. 

Clinically Meaningful Itch Relief 

Supporting clinical data include findings from the phase 3 GLISTEN trial, which included 238 adults with PBC and moderate-to-severe pruritus across 115 centers in 19 countries. 

Participants received oral linerixibat 40 mg twice daily or matching placebo for 24 weeks, stratified by baseline pruritus severity and concomitant use of bile acid binding resins.

Linerixibat demonstrated a significant reduction in itching severity compared with placebo over 24 weeks, achieving a least-squares mean change from baseline of -2.86 vs -2.15 for placebo (adjusted mean difference, -0.72). 

These efficacy gains were accompanied by improvements in pruritus-related sleep interference. 

Dosing, Safety, and Tolerability 

The most frequently reported adverse events were gastrointestinal, particularly diarrhea and abdominal pain. Diarrhea occurred in 61% of patients receiving linerixibat compared with 18% receiving placebo, while abdominal pain was reported in 18% and 3%, respectively. Transaminase elevations were also commonly reported. 

Lynavoy will be supplied as 40-mg film-coated tablets. 

Full prescribing guidance will appear in the summary of product characteristics, to be published in all official EU languages once the European Commission grants marketing authorization.