Boxed warning added to Ocaliva label

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) announced the addition of a boxed warning to FDA's label of Ocaliva obeticholic acid stating that hepatic decompensation and failure can occur in incorrectly dosed primary biliary cholangitis (PBC) patients with Child-Pugh Class B or C hepatic impairment or decompensated cirrhosis.

The news could remove an overhang on Intercept's stock. Some investors had been concerned that FDA could implement stronger measures, such as limiting the drug's use to patients with milder disease, holding an advisory committee meeting or otherwise restricting Ocaliva's use. Intercept said the warning addresses about 2-3% of the PBC patient population...