Shots:
- The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing
- Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus
- Trial met its 1EP & key 2EPs showing rapid (at wk. 2) & sustained (over 24wks.) improvement in cholestatic pruritus along with reduced itch-related sleep interference
Ref: GSK | Image: GSK | Press Release
Related News: GSK Licenses Linerixibat’s Global Rights to Alfasigma in ~$690M Deal
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