By FieldPulse Staff · March 21, 2026
Tags: fda-approval, rare-disease, gsk, hepatology
The FDA approved linerixibat (Lynavoy) on March 19, marking the first-ever approved treatment for cholestatic pruritus in primary biliary cholangitis — a chronic, debilitating symptom with no prior standard of care. Commercialization rights belong to Alfasigma, not GSK.
The FDA granted approval to linerixibat (brand name Lynavoy) on March 19, 2026 — four days ahead of its PDUFA date — for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). It is the first drug ever approved specifically for this indication. Primary biliary cholangitis is a rare, chronic autoimmune liver disease predominantly affecting women between the ages of 40 and 60. Cholestatic pruritus — severe, chronic itching caused by bile acid accumulation — is one of its most debilitating symptoms and has had no approved pharmacological treatment until no