Intercept’s OCA In NASH: ‘Modest’ Effect On Surrogate Comes With ‘Substantial’ Risks, US FDA Says
Executive Summary
Ahead of advisory committee vote on accelerated approval, agency takes a dim view of obeticholic acid's benefit-risk balance for the treatment of liver fibrosis due to NASH, citing risks of drug-induced liver injury and morbidity associated with biopsies necessary for appropriate patient selection.
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