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FDA panel unanimously backs Intercept's Ocaliva

April 8, 2016 12:40 AM UTC

Members of FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted 17-0 that there is substantial evidence to support accelerated approval of Ocaliva obeticholic acid ( OCA) from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) to treat primary biliary cholangitis (PBC).

Panelists mostly agreed that alkaline phosphatase (ALP) is a biomarker likely to predict benefit in early stage PBC. FDA had preferred that Intercept show Ocaliva's efficacy on a composite endpoint using both ALP and total bilirubin (TB), but few patients in the lone pivotal study in Ocaliva's NDA had TB levels outside the normal range. ...