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Replacement RNS: Linerixibat file accepted by EMA
Replacement RNS: Linerixibat file accepted by EMA.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 23 June 2025, London UK\n \nLinerixibat accepted for review by the European Medicines Agency for cholestatic pruritus in patients with primary biliary cholangitis (PBC)\n \n· If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference\n· Submission based on data from positive GLISTEN phase III trial\n \n \n \nGSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency 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.\n \nKaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: \"The EMA acceptance of this file marks another significant step forward in the progress of linerixibat, following FDA acceptance earlier this month. We believe linerixibat has the potential to bring relief to patients living with relentless itch associated with PBC, a condition that often disrupts sleep, and for which there are currently few effective treatment options available.\"\n \nThe 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. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.\n \nLinerixibat is currently not approved anywhere in the world.\n \nAbout cholestatic pruritus in PBC\nIn PBC, a cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease or biochemical control, and is experienced in varying degrees of severity by up to 90% of people living with PBC.1 The first line treatment for PBC controls disease ...