Intercept Pharmaceuticals, Inc.’s obeticholic acid (OCA) has a “modest” treatment effect on a surrogate endpoint but poses “substantial” risks in the treatment of nonalcoholic steatohepatitis (NASH) that cannot be readily mitigated, the US Food and Drug Administration said.
Intercept’s OCA In NASH: ‘Modest’ Effect On Surrogate Comes With ‘Substantial’ Risks, US FDA Says
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.
