GSK plc GSK announced that the European Medicines Agency has accepted its marketing authorization application (MAA) seeking ...

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

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 ...

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 ...

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 ...

GSK plc (LSE/NYSE:GSK) announced Monday that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for linerixibat, an investigational treatment for ...

· 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 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 ...

The FDA has accepted for review the NDA for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

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 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 ...