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Gilead's Livdelzi Gains Accelerated FDA Approval for Primary Biliary Cholangitis

Aug 14, 2024, 06:06 PM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences for its liver disease treatment, Livdelzi (Seladelpar). This approval is specifically for the treatment of primary biliary cholangitis (PBC), an autoimmune liver disease that primarily affects women. The drug, which demonstrated significant improvements in liver disease markers and pruritus, was acquired through Gilead's $4.3 billion buyout of CymaBay Therapeutics earlier this year.