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Lynavoy (linerixibat) approved by US FDA
GSK plc announced that the US FDA has approved Lynavoy (linerixibat) for cholestatic pruritus in adult patients with primary biliary cholangitis (PBC), marking the first US approval for this indication. This ileal bile acid transporter inhibitor, which reduces itch drivers, is based on positive Phase III GLISTEN trial data, with regulatory reviews ongoing in the EU, UK, Canada, and China. GSK previously announced a license agreement for worldwide rights to linerixibat with Alfasigma S.p.A., which is subject to customary conditions. Cholestatic pruritus affects up to 89% of PBC patients and can significantly impair quality of life. Disclaimer*
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[{"type":"text","content":"\n\nIssued: 19 March 2026, London UK\n \nLynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC)\n \n· Lynavoy, an ileal bile acid transporter (IBAT) inhibitor, is the first medicine approved in the US for the treatment of cholestatic pruritus in patients with PBC\n· Up to 89% of people living with PBC experience cholestatic pruritus, an internal itch with a debilitating impact on quality of life1-4\n· Approval based on the positive GLISTEN phase III trial with regulatory reviews underway in the EU, UK, Canada and China\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication.5\n \nGSK previously announced on 9 March a licence agreement under which Alfasigma S.p.A. will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat. This transaction is ongoing and is subject to customary conditions, including applicable regulatory agency clearances such as under the Hart-Scott-Rodino Act in the US.\n \nCholestatic pruritus is an internal itch experienced by up to 89% of people living with PBC, a rare autoimmune disease that can lead to liver failure.1-4 It is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.3,6,7\n \nKaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation, and Head of GSK Translational & Development Sciences, GSK, said: \"The approval of Lynavoy in the US gives patients a much needed treatment option that offers rapid, significant and sustained improvement in the debilitating effects of itch caused by PBC. For many patients, cholestatic pruritus remains a persistent, poorly addressed condition. This is the first liver medicine from our pipeline to receive approval, underscoring our commitment to developing meaningful innovation across the spectrum of liver d...