Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim

Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat.

Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis (PBC), the FDA’s council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval of its farnesoid X receptor agonist.