Posted by Michael Wonder on 05 Jun 2025
Linerixibat new drug application accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
2 June 2025 - GSK today announced the US FDA has accepted for review the new drug application for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, a rare auto-immune liver disease.
The PDUFA goal date is 24 March 2026.
