Approval of Lynavoy (linerixibat) for the treatment of pruritus in adults with PBC in the UK

MHRA announced the approval of Lynavoy (linerixibat; IBATi) for the treatment of pruritus in adults with PBC in the UK, representing the first approval in the EU region following US FDA approval in March 2026.

Key details:

• The approval was supported by data from the Phase 3 GLISTEN trial (N=238; PCD: Oct 2024), which randomized patients with PBC to linerixibat 40 mg twice daily or placebo for 24 weeks
  • The trial met its primary endpoint (Monthly Itch Score; WI-NRS), demonstrating a statistically significant reduction in pruritus and improvement in itch-related sleep disruption versus placebo
• The MHRA noted it will continue to closely monitor the safety and effectiveness of linerixibat as it is used more widely

assessment:

• MHRA approval marks the first approval for Lynavoy outside of the US (Mar 2026) and review remains underway in CN, EU and Canada 
  • EU approval expected in Q3 2026, following inclusion in the CHMP March agenda
  • China approval anticipated in Q3 2026 following NMPA review acceptance in Feb 2026
  • Japan submission acceptance expected in H1 2026, with approval guided for 2027
• Regarding Lynavoy’s reimbursement potential, NICE appraisal is currently listed as "Awaiting development," with the appraisal anticipated to begin in August 2026 and a guidance publication expected by January 2027