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Author Topic: FDA Delays Approval of Ocaliva for Fatty Liver Disease  (Read 9214 times)

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Offline Hep Editors

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FDA Delays Approval of Ocaliva for Fatty Liver Disease
« on: November 13, 2020, 11:23:52 am »
The Food and Drug Administration (FDA) indicated in late June that it would not approve Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for the treatment of fibrosis related to non-alcoholic steatohepatitis until more data are available, the company announced. This delays the debut of a first approved therapy for the increasingly common and potentially serious liver condition.

However, as Arun Sanyal, MD, of Virginia Commonwealth University noted at a fatty liver disease symposium sponsored by the Nutrition Obesity Research Center at Harvard, if the agency thought the drug was “ineffective or toxic,” they likely would have stopped an ongoing clinical trial of the drug.



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