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LONDON - The European Medicines Agency has accepted for review GSK’s (LSE/NYSE:GSK) marketing authorization application for linerixibat, an investigational treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC), the company announced Monday.
The application follows the FDA’s acceptance of the submission earlier this month. If approved, linerixibat would address an unmet medical need for patients suffering from relentless itch associated with this rare autoimmune liver disease.
The submission is supported by data from the GLISTEN phase III trial presented in May at the European Association for the Study of the Liver Congress. The study met both primary and key secondary endpoints, demonstrating significant improvement in cholestatic pruritus and itch-related sleep interference compared to placebo.
"We believe linerixibat has the potential to bring relief to patients living with relentless itch associated with PBC, a condition that often disrupts sleep, and for which there are currently few effective treatment options available," said Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D at GSK.
Cholestatic pruritus affects up to 90% of people with PBC in varying degrees of severity. The condition occurs when bile flow from the liver is disrupted, causing excess bile acids in circulation. Current first-line treatments for PBC control the disease in approximately 70% of patients but do not reduce pruritus severity.
Linerixibat works by inhibiting bile acid re-uptake, which reduces multiple mediators of pruritus in circulation. The drug has received orphan drug designation from both the FDA and EMA for treating cholestatic pruritus in PBC patients.
The GLISTEN trial involved 238 PBC patients with moderate to severe itch across 19 countries. Linerixibat is currently not approved anywhere in the world.
This article is based on a press release statement from GSK.
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