FDA Approves Linerixibat (Lynavoy) for Cholestatic Pruritus in PBC — A First-in-Class Approval for Severe Itching
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 now.
Existing PBC drugs like obeticholic acid (Ocaliva, Intercept) and fibrates target disease progression rather than itch specifically.
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor — it blocks the reabsorption of bile acids in the gut, reducing the circulating bile acid pool and thereby relieving pruritus.
The Phase 3 GLISTEN trial demonstrated significant itch reduction from week 2, sustained over 24 weeks versus placebo on both the primary and key secondary endpoints.
The commercial reality for reps is an important nuance: GSK originated linerixibat but licensed all global commercialization rights to Alfasigma S.p.A.
on March 9, 2026 — ten days before the FDA approval.
Alfasigma, an Italian specialty pharma company with a U.S.
commercial presence, will develop, manufacture, and commercialize Lynavoy worldwide.
What it means for reps: This is an Alfasigma launch, not a GSK launch.
Hepatologists and gastroenterologists managing PBC patients will be the primary targets.
The approved indication is narrow but completely uncontested — there is no competition in cholestatic pruritus.
Reps at Intercept (Ocaliva) and Ipsen (Elafibranor, a PBC disease-modifying agent) should expect Alfasigma to begin building its hepatology presence rapidly.
Source: https://www.gsk.com/en-gb/media/press-releases/lynavoy-linerixibat-approved-by-the-us-fda/