23rd Jun 2025 09:55
(Alliance News) - GSK PLC on Monday said linerixibat has been accepted for review by the European Medicines Agency for the treatment of intense itching caused by a rare autoimmune liver disease.
The London-based pharmaceutical company said the agency has accepted for review the marketing authorisation application to treat cholestatic pruritus in patients with primary biliary cholangitis.
Cholestatic pruritus is described as a relentless itch which disrupts sleep.
Linerixibat, which is currently not approved anywhere in the world, is a targeted inhibitor of the ileal bile acid transporter.
The application is based on positive data from the Glisten phase three trial, which met both primary and key secondary endpoints.
It demonstrated a "rapid, significant and sustained improvement" in cholestatic pruritus and itch-related sleep interference compared to the placebo.
"The EMA acceptance of this file marks another significant step forward in the progress of linerixibat, following FDA acceptance earlier this month," said Senior Vice President Kaivan Khavandi.
"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."
Shares in GSK were up 0.3% at 1,407.00 pence in London on Monday morning.
By Michael Hennessey, Alliance News reporter
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