BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - GSK plc (GSK) announced the FDA has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis. The PDUFA goal date is 24 March 2026.
The company said its application is based on positive data from the GLISTEN phase III trial, presented in May at the European Association for the Study of the Liver Congress. Linerixibat is currently not approved anywhere in the world.
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