FDA Approves Gilead's $4.3B Acquisition Drug Livdelzi for PBC

Aug 14, 2024, 07:23 PM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences' drug Livdelzi (Seladelpar) for the treatment of primary biliary cholangitis (PBC), an autoimmune liver disease that primarily affects women. This approval follows Gilead's acquisition of CymaBay Therapeutics for $4.3 billion earlier this year. The treatment, which is used in combination with ursodeoxycholic acid, demonstrated significant improvements in liver disease markers and pruritus. The approval is based on data from the Phase 3 RESPONSE study and marks Gilead's first launch of an inflammatory drug.