GSK’s Lynavoy approved for cholestatic pruritus in patients with primary biliary cholangitis

GSK has recently announced that the US FDA has approved Lynavoy for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid transporter inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication.

GSK announced on 9th March a licence agreement under which Alfasigma S.p.A. will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat.

Note that Cholestatic 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. 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.

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.”

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.”

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.”

 

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Related Topics and Keywords

cholestatic pruritus, GSK, Lynavoy (linerixibat), primary biliary cholangitis