GSK plc GSK announced that the European Medicines Agency has accepted its marketing authorization application (MAA) seeking approval of its investigational ileal bile acid transporter (“IBAT”) ...

EMA accepts GSK’s MAA for linerixibat for cholestatic pruritus in patients with primary biliary cholangitis: London, UK Tuesday, June 24, 2025, 09:00 Hrs [IST] GSK plc announced ...

The EMA has started a review of GSK's treatment candidate for primary biliary cholangitis (PBC), linerixibat, offering hope ...

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 ...

Linerixibat, a targeted inhibitor of the ileal bile acid transporter (IBAT), is not currently approved in any country. It is also under regulatory review in the US and UK.

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 ...

· If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference · Submission based on data from ...

Linerixibat was also associated with significant improvements in key secondary endpoints vs placebo, including itch score at week 2 (P <.001) and itch-related sleep interference over 24 weeks (P ...

A regulatory filing seeking approval for linerixibat for the given indication is currently under review in the United States. A final decision from the FDA is expected on March 24, 2026.