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LONDON - The European Medicines Agency has accepted 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 drug’s acceptance for review by the FDA earlier this month. If approved, linerixibat would target the persistent itching associated with PBC, a rare autoimmune liver disease.
The submission is supported by results from the GLISTEN phase III trial, which demonstrated significant improvement in cholestatic pruritus and itch-related sleep interference compared to placebo. The trial data was presented in May at the European Association for the Study of the Liver Congress.
"We believe linerixibat has the potential to bring relief to patients living with relentless itch associated with PBC," said Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D at GSK, according to the press release.
Cholestatic pruritus affects up to 90% of people with PBC and can significantly impact quality of life. The condition occurs when bile flow from the liver is disrupted, causing excess bile acids in circulation. Current first-line treatments for PBC do not adequately address the pruritus symptoms.
Linerixibat works by inhibiting the ileal bile acid transporter (IBAT), reducing mediators of pruritus in circulation. Both the FDA and EMA have granted the drug orphan designation for treating cholestatic pruritus in PBC patients.
The GLISTEN trial involved 238 PBC patients with moderate to severe itch across 19 countries. The drug is not currently approved in any market.
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