Gilead Sciences Receives European Commission Approval for Livdelzi in Primary Biliary Cholangitis

Gilead Sciences today announced that the European Commission has approved Livdelzi (seladelpar) for the treatment of adults with primary biliary cholangitis (PBC) who have an inadequate response to ursodeoxycholic acid (UDCA) or who are unable to tolerate UDCA in the European Union. The approval was based on results from the Phase 3 RESPONSE trial, which demonstrated a statistically significant biochemical response rate of 61.7% compared to 20% for placebo. This approval makes Livdelzi available to PBC patients across all EU member states. Gilead is committed to ensuring broad patient access to Livdelzi in Europe.