GSK reports linerixibat NDA accepted for review by FDA

GSK (GSK) plc announced the U.S. Food and Drug Administration has accepted for review the New Drug Application for linerixibat, 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. The Prescription Drug User Fee Act, or PDUFA, goal date is March 24, 2026. Linerixibat is currently not approved anywhere in the world, the company noted. Kaivan Khavandi, SVP, 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.”