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FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

May 17, 2023


Food and Drug Administration scientists reviewing what could become the first medicine for the fatty liver disease NASH are skeptical the treatment’s safety risks outweigh its “modest” benefits, according to documents made public Wednesday.

The documents were posted online ahead of a Friday advisory committee meeting on the drug, known as obeticholic acid, or OCA, and developed by biotechnology company Intercept Pharmaceuticals. Panelists are being asked whether the FDA should grant the treatment an “accelerated” approval based on biological markers, or defer a decision until Intercept has data from an ongoing Phase 3 trial. That trial is testing the drug’s impact on health outcomes, but results aren’t expected until 2025.

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