Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim
Fierce Pharma
SEPTEMBER 16, 2024
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, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.
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