The US Food and Drug Administration (FDA) has rejected Intercept Pharmaceutical’s second bid for approval of obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with stage 2 or 3 fibrosis.
The move follows the recommendation from last month’s FDA Gastrointestinal Drugs Advisory Committee meeting. During the meeting, members voted 15 to 1 to advise deferring approval until clinical outcome data became available. Intercept’s clinical trial data demonstrated that OCA showed moderate benefit over placebo in improving fibrosis in NASH patients, but “there is uncertainty how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes,” an FDA meeting briefing document stated. There were also notable safety concerns including an increased risk for drug-induced liver injury.
An estimated 16.8 million Americans have NASH, and there are no FDA-approved medications for the condition.
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