GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment

Positive Phase 3 Results:
GSK's linerixibat has shown positive results in a Phase 3 trial for treating cholestatic pruritus in patients with Primary Biliary Cholangitis (PBC), meeting its primary endpoint with a statistically significant improvement in itch over 24 weeks compared to placebo[2][3].

Regulatory Filings:
Following the successful trial, GSK is planning to submit regulatory filings for linerixibat, aiming to make it the first global therapy indicated to treat itch in PBC[2][5].

Market Potential:
The success of linerixibat opens up an untapped market for treating PBC itch, a condition with limited treatment options[5].

Trial Details:
The trial included PBC patients with moderate to severe itch who were receiving stable doses of guideline-suggested therapies for pruritus[4].

Competitive Landscape:
Linerixibat's potential approval could position it as a leading treatment for PBC itch, competing with existing treatments like Ipsen's IBAT inhibitor[5].