09:39 AM EDT, 06/02/2025 (MT Newswires) -- GSK (GSK) said Monday that its new drug application for linerixibat has been accepted for review by the US Food and Drug Administration for cholestatic pruritus, or relentless itch, in patients with autoimmune liver disease primary biliary cholangitis.

The company said March 24, 2026, is the Prescription Drug User Fee Act goal date for linerixibat, which is currently not approved anywhere in the world.

The application is based on a phase 3 trial that showed improvement in cholestatic pruritus and itch-related sleep interference compared with placebo, the drugmaker said.

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