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GSK PLC on Monday announced the US Food & Drug Administration has accepted for review the new drug application for its liver disease treatment, linerixibat. The London-based pharmaceuticals company said 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 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, GSK said. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition, it added. Linerixibat is an investigational targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. Kaivan Khavandi, senior vice president, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said: ‘The FDA’s acceptance of this file is an important milestone in the development of linerixibat. We believe that linerixibat has the potential to make a difference in the lives of patients living with relentless itch associated with PBC and its related sleep interference. These are debilitating symptoms which currently have very limited treatment options.’ The prescription drug user fee act goal date is March 24, 2026. Linerixibat is currently not approved anywhere in the world, GSK noted. Shares in GSK were 0.4% higher at 1,513.00 pence each in London on Monday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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