FDA Approves Lynavoy as First Treatment for Itch in Primary Biliary Cholangitis

Phase III GLISTEN trial data supports approval of the first therapy specifically targeting cholestatic pruritus in PBC patients.

The FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, marking the first dedicated therapy for this debilitating symptom.

Backed by Phase III GLISTEN trial results, the drug demonstrated rapid and sustained improvements in itch and sleep interference, addressing a significant unmet need in liver disease management.

Alert Type	Drug Approval (FDA)
Drug/Device Name	Lynavoy (linerixibat)
Indication	Cholestatic pruritus in patients with primary biliary cholangitis (PBC)
Therapy Area(s)	Hepatology / Liver Disease
Geography	US (FDA)
What Changed	The FDA approved Lynavoy, the first therapy for cholestatic pruritus linked to PBC, following Phase III GLISTEN trial results showing rapid and sustained improvement in itch and sleep interference compared to placebo.
Clinical Relevance	Provides the first dedicated treatment for PBC-related itch, addressing a previously unmet symptom with significant impact on patient quality of life.
Source Link	https://www.gsk.com/en-gb/media/press-releases/fda-approves-lynavoy-for-pruritus-in-pbc/
Date	19-Mar-2026
Status	Draft
Notes	GLISTEN Phase III trial met primary and key secondary endpoints; market competition includes PPAR agonists Livdelzi (seladelpar) and Iqirvo (elafibranor); Alfasigma licensing deal includes upfront $300M, $100M on approval, plus EU/UK milestones and royalties; Lynavoy under review in EU and UK; first liver medicine from GSK’s pipeline to receive approval.

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