By Fineline Cube 
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for linerixibat, an ileal bile acid transporter (IBAT) inhibitor. The application seeks approval for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).
Clinical Trial Results
The MAA submission is supported by positive outcomes from the Phase III GLISTEN study, which met its primary and key secondary endpoints. Linerixibat demonstrated rapid, significant, and sustained efficacy in reducing the severity of cholestatic pruritus and pruritus-related sleep disturbances compared to placebo.
Global Regulatory Review
Linerixibat is also under review by the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), highlighting GSK’s commitment to addressing unmet medical needs in PBC.-Fineline Info & Tech