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
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.