Parere positivo del CHMP per Lynavoy (linerixibat) nel trattamento del prurito negli adulti affetti da colangite biliare primitiva (PBC)

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of linerixibat in the EU for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). 

The EC decision typically follows within ~67 days, placing anticipated EU approval around Sep 2026.

Positive opinion is 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), and key secondary endpoints, demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition. 

Alfasigma highlighted that up to 89% of patients with PBC experience pruritus, and if approved, linerixibat will be the first approved IBAT inhibitor for cholestatic pruritus in the EU.

This opinion follows the drug's US FDA approval in March 2026, and reviews remain ongoing in CN, the UK, and Canada; JP regulatory submission acceptance remains expected, with an anticipated approval guided for 2027.  

Alfasigma Press Release