By Fineline Cube 
UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that the New Drug Application (NDA) for its investigational drug linerixibat has been accepted for review by the US Food and Drug Administration (FDA). The application seeks approval for linerixibat as a treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC).
Clinical Trial Success
The filing is supported by positive results from the Phase III GLISTEN study, which met both primary and secondary endpoints. In the study, linerixibat demonstrated a rapid, significant, and sustained therapeutic effect compared to placebo. It effectively relieved cholestatic itching and improved itch-related sleep impairment in patients with PBC.-Fineline Info & Tech