19th Mar 2026 12:20
(Alliance News) - GSK PLC on Thursday said the US Food & Drug Administration approved Lynavoy for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.
The London-based pharmaceutical company said the approval of the ileal bile acid transporter inhibitor is the first medicine approved in the US for the treatment of cholestatic pruritus in patients with primary biliary cholangitis, PBC.
PBC is a liver disease under which the immune system mistakenly attacks the bile ducts. Symptoms may include bone and joint aches, extreme tiredness, itchy skin, dry eyes and mouth and pain or discomfort in the upper right side of the tummy.
GSK said Lynavoy, also known as linerixibat, reduces multiple drivers of chronic itch.
The approval of Lynavoy is based on positive phase 3 trial data with regulatory reviews underway in the EU, UK, Canada and China.
GSK said that up to 89% of people living with PBC experience cholestatic pruritus, an internal itch "with a debilitating impact on quality of life."
"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," said Kaivan Khavandi, research & development head at Respiratory, Immunology & Inflammation, and head of GSK Translational & Development Sciences at GSK.
GSK shares fell 1.3% to 1,947.00 pence each on Thursday afternoon in London.
By Tom Budszus, Alliance News slot editor
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