GSK's linerixibat to be reviewed by US FDA

(Sharecast News) - Drugmaker GSK revealed on Monday that a new drug application for its linerixibat asset had been accepted for review by the US Food and Drug Administration for use in cholestatic pruritus patients with primary biliary cholangitis. GSK said its application for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease, was based on "positive data" from its GLISTEN phase III trial. GLISTEN met both primary and key secondary endpoints, demonstrating "a rapid, significant and sustained improvement" in cholestatic pruritus and itch-related sleep interference versus placebo.

The London-listed firm noted that linerixibat's Prescription Drug User Fee Act goal date was 24 March 2026.

GSK's Kaivan Khavandi said: "The FDA's acceptance of this file is an important milestone in the development of linerixibat. We believe that linerixibat has the potential to make a difference in the lives of patients living with relentless itch associated with PBC and its related sleep interference. These are debilitating symptoms which currently have very limited treatment options."

As of 0820 BST, GSK shares were up 0.53% at 1,515.0p.





Reporting by Iain Gilbert at Sharecast.com