GSK announces EMA has accepted for review the MAA for use of linerixibat

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the marketing authorisation application, MAA, for the use of linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, IBAT, for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. The 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, EASL, Congress. 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.