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GSK plc (LSE/NYSE:GSK) announced Monday that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for linerixibat, an investigational treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). This information is based on a press release statement included in a recent SEC filing.
Linerixibat is a targeted inhibitor of the ileal bile acid transporter (IBAT) and is intended for patients with PBC, a rare autoimmune liver disease. According to GSK, the application is supported by positive results from the GLISTEN phase III trial, which met both primary and key secondary endpoints. The study demonstrated rapid, significant, and sustained improvement in cholestatic pruritus and itch-related sleep interference compared to placebo. The safety profile was reported as consistent with previous studies and the mechanism of IBAT inhibition.
The GLISTEN trial was a double-blind, randomized, placebo-controlled phase III study involving 238 patients with PBC and moderate to severe itch. Participants were enrolled equally into active and placebo arms. The trial was conducted across 19 countries, including the Americas, Europe, China, and Japan.
Linerixibat is not currently approved in any country. The product is also under regulatory review in the United States and the United Kingdom (TADAWUL:4280), and has received orphan drug designation from both the US Food and Drug Administration and the EMA for the treatment of cholestatic pruritus in PBC patients.
Cholestatic pruritus is a condition characterized by persistent itching due to disrupted bile flow in the liver. It affects up to 90% of people with PBC and can lead to sleep disturbance, fatigue, and impaired quality of life.
This article is based on information provided in a press release statement included in a recent SEC filing.
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