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Testimony before the FDA’s Gastrointestinal Drugs Advisory Committee regarding the possible accelerated approval of obeticholic acid (NDA# 212833) to treat nonalcoholic steatohepatitis with fibrosis

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In testimony before the Food and Drug Administration’s (FDA’s) Gastrointestinal Drugs Advisory Committee, Public Citizen urged the committee to reject accelerated approval for obeticholic acid (a synthetic bile acid) as a treatment for fatty liver disease because of inadequate efficacy on two surrogate endpoints and because of many safety concerns that included drug induced liver disease.