Gilead Receives FDA Approval for Seladelpar in Primary Biliary Cholangitis

Gilead Sciences today announced that the FDA has approved Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in adults who have an inadequate response to or are unable to tolerate ursodeoxycholic acid (UDCA). Seladelpar is a selective PPAR-delta agonist that demonstrated significant reductions in alkaline phosphatase and improvements in pruritus in the Phase 3 RESPONSE trial. This approval provides a new treatment option for PBC patients with inadequate UDCA response and represents a novel mechanism of action in this rare liver disease.