Shots:
- The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026)
- NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial
- Trial met its 1EP of reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, plus its 2EPs showed rapid & sustained itch relief along with reduced itch-related sleep interference; data was presented at EASL 2025
Ref: GSK | Image: GSK | Press Release
Related News:- GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
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