Positive Panel, But What's Ahead For Intercept's Ocaliva?
This article was originally published in Scrip
Executive Summary
After the FDA's glowing review on paper and even more so at the meeting of the agency's Gastrointestinal Drugs Advisory Committee, it was highly likely the panel would back a speedy approval of Intercept Pharmaceuticals Inc.'s Ocaliva (obeticholic acid) as a treatment for primary biliary cholangitis (PBC), a rare and potentially fatal liver disease.