LONDON (dpa-AFX) - GSK plc (GSK), Monday confirmed that the European Medicines Agency has accepted its marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, to treat cholestatic pruritus in primary biliary cholangitis. The submission follows FDA acceptance earlier this month.
The MAA is supported by data from the Phase III GLISTEN trial, in which linerixibat delivered rapid, significant and sustained reductions in itch severity and itch-related sleep interference versus placebo, with a safety profile consistent with previous studies.
Cholestatic pruritus affects up to 90 percent of PBC patients and can severely impair quality of life. Linerixibat currently holds orphan drug designation in the US and EU and remains under review for approval globally.
GSK is currently trading at $37.99, down $0.08 or 0.22 percent on the New York Stock Exchange.
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