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GSK Wins European Medicines Agency's Positive Opinion on Lynavoy for Liver Disease-Related Itch

MT Newswires·07/24/2026 06:54:16
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06:54 AM EDT, 07/24/2026 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization approval for GSK's (GSK.L) Lynavoy tablets for the treatment of cholestatic pruritus in adults with primary biliary cholangitis, an autoimmune liver disease. The Lynavoy, or linerixibat, inhibits the ileal bile acid transporter, reducing the reabsorption of bile acids from the gut to improve cholestatic pruritus, according to a Friday notice. The positive opinion is based on the global phase 3 study that showed the Lynavoy treatment led to improvement in the monthly itch score over 24 weeks when compared with placebo, with additional benefits in pruritus-related sleep interference.