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BioWorld - Thursday, December 11, 2025
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Home » Intercept faces a skeptical FDA in rare liver disease adcom
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Intercept faces a skeptical FDA in rare liver disease adcom

Sep. 13, 2024
By Lee Landenberger
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
BioWorld Regulatory Gastrointestinal Small molecule U.S. Accelerated review FDA

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