GSK Reports the EMA’s MAA Acceptance of Linerixibat for Cholestatic Pruritus
Shots:
- The EMA has accepted the MAA of Linerixibat to treat cholestatic pruritus in pts with primary biliary cholangitis (PBC)
- MAA was supported by the P-III (GLISTEN) study (n=238), which showed that Linerixibat significantly and sustainably improved cholestatic pruritus and itch-related sleep interference, meeting all 1EPs & 2EPs. The safety profile aligned with previous studies. Conducted across 19 countries; presented at the EASL’25
- Linerixibat is an oral IBAT inhibitor that targets cholestatic pruritus in PBC by blocking bile acid reuptake, thereby reducing itch-related mediators in circulation
Ref: GSK | Image: GSK| Press Release
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