FDA Accepts GSK's NDA for Linerixibat in Rare Disease-Related Itch
Key Takeaways GSK's NDA for linerixibat in cholestatic pruritus tied to PBC has been accepted by the FDA for review. The NDA is based on GLISTEN study data showing rapid and sustained itch relief versus placebo. If approved, linerixibat could be the first global therapy for PBC-related itch and sleep disruption.GSK plc (GSK) announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval of its investigational targeted inhibitor of the ileal bile acid transporter (“IBAT”), ...