Gilead Sciences Receives FDA Approval for Livdelzi 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 ursodeoxycholic acid (UDCA) or who are unable to tolerate UDCA. Livdelzi is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. In the Phase 3 RESPONSE trial, Livdelzi demonstrated a statistically significant biochemical response rate of 61.7% compared to 20% for placebo. Additionally, Livdelzi significantly reduced pruritus, a debilitating symptom of PBC. This approval provides patients with PBC a new treatment option to slow disease progression.