Gilead Sciences Inc. (GILD) announced that the U.S. Food and Drug Administration has granted accelerated approval for Livdelzi (seladelpar) to treat primary biliary cholangitis or PBC. Livdelzi can be used in combination with ursodeoxycholic acid or UDCA in adults who have not responded adequately to UDCA, or as a monotherapy for patients who cannot tolerate UDCA. However, Livdelzi is not recommended for individuals with or who develop decompensated cirrhosis.
The FDA approved Livdelzi under accelerated approval based on a reduction of alkaline phosphatase. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s), the company said.
Primary biliary cholangitis is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and can cause liver damage and possible liver failure if untreated. The disease currently has no cure.
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