Shots:
- The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada
- NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts with cholestatic pruritus in 2 parts
- Trial met its 1 & 2EPs, showing rapid & sustained itch relief along with reduced itch-related sleep interference; data were presented at EASL 2025
Ref: GSK | Image: GSK | Press Release
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