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Will Livdelzi receive full FDA approval for PBC by end of 2024?
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Resolution / Starting Odds
Yes • 50%
No • 50%
FDA official announcements and website
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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.
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FDA approval granted • 25%
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