The U.S. Food and Drug Administration (FDA) has approved linerixibat, marketed as Lynavoy, to treat itching in adults with primary biliary cholangitis (PBC), GSK announced in a recent press release.
Linerixibat is an ileal bile acid transporter inhibitor that addresses chronic itching in PBC, also known as cholestatic pruritis. It is the first drug approved in the United States to manage this symptom, which impacts up to 89% of patients with PBC.
“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,” said Dr. Christopher Bowlus, chief of gastroenterology and hepatology at the University of California, Davis. “The impact of itch on people living with PBC can be profound and treatment options have until now been limited.”
Approval was based on findings from the Phase III GLISTEN clinical trial (NCT04950127). The study randomized 238 adults with PBC and moderate to severe itch to receive either linerixibat or a placebo. Individuals taking linerixibat reported significant improvements in itching and itch-related sleep interference at both two weeks and 24 weeks, suggesting a rapid and sustained response.
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The safety profile of linerixibat was consistent with that observed in prior studies. The most common side effects included diarrhea (61%) and abdominal pain (18%). The majority of cases were mild to moderate, though 4% of patients discontinued treatment with linerixibat due to diarrhea and 4% discontinued due to abdominal pain. Conversely, fewer than 1% of patients receiving placebo discontinued treatment due to diarrhea, and none discontinued due to abdominal pain.
Linerixibat previously received Orphan Drug designation in the United States, the European Union and Japan. GSK is also applying for marketing authorization in the European Union, United Kingdom, Canada and China.
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