FDA advisory committee members backed accelerated approval of Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid) for primary biliary cirrhosis but suggested modifications to an ongoing confirmatory trial, as well as additional post-marketing studies, may be needed to address uncertainties left in the wake of the lone Phase III trial.
Intercept's Cirrhosis Endpoint Gets FDA Panel Nod For Accelerated Approval
But advisory committee members echo FDA concerns about sponsor's ability to complete placebo-controlled confirmatory trial for the obeticholic acid product and weigh changes in enrollment criteria for ongoing study.
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