FDA Approves GSK’s Lynavoy As First US Therapy For Cholestatic Pruritus In Primary Biliary Cholangitis

GSK plc announced that the U.S. Food and Drug Administration has approved Lynavoy (linerixibat) to treat cholestatic pruritus in adults with primary biliary cholangitis (PBC). Lynavoy, an ileal bile acid transporter inhibitor, works by reducing key biological drivers of chronic itching and becomes the first approved therapy in the United States specifically for this condition.

Kaivan 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 disease.”

Earlier, GSK entered a licensing agreement with Alfasigma S.p.A. granting the company exclusive global rights to develop, manufacture, and commercialize linerixibat. The deal remains in progress and is subject to standard closing requirements, including regulatory clearances such as those required under U.S. antitrust regulations.

Christopher Bowlus M.D., Lena Valente Professor and Chief of Gastroenterology and Hepatology, University of California Davis, said: “The approval of linerixibat represents an important opportunity to improve the lives of people with PBC and who struggle with uncontrolled and often debilitating pruritus. The impact of itch on people living with PBC can be profound and treatment options have until now been limited. The FDA’s decision marks a major milestone in PBC pruritus care that addresses a critical area of unmet need.”

Cholestatic pruritus is a severe internal itching condition affecting the majority of people living with PBC, a rare autoimmune liver disease that can progress to liver failure. The symptom can be highly debilitating, frequently causing sleep disruption, persistent fatigue, reduced quality of life, and in some cases leading to liver transplantation even when liver function remains relatively preserved.

Carol Roberts, President, The PBCers Organization, said: “Cholestatic pruritus has been underestimated and overlooked for far too long, despite its significant impact on people living with PBC. Seeing a treatment specifically developed for chronic itch finally reach patients is a significant step forward and offers hope for those in need.”

The FDA approval is supported by results from the global Phase III GLISTEN trial, which achieved both primary and key secondary endpoints. Patients treated with linerixibat experienced rapid itch relief within two weeks and sustained improvements over 24 weeks, including reductions in itch-related sleep disturbance, compared with placebo. The therapy has received Orphan Drug Designation in the U.S., EU, and Japan, along with priority review status in China, while regulatory submissions remain under review in several major markets.