FDA adds 'Boxed Warning' to highlight correct dosing for Ocaliva

The US Food and Drug Administration is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury.

In June 2016, the FDA granted accelerated approval to liver disease drug Ocaliva, the lead product of US biopharma Intercept Pharmaceuticals (Nasdaq: ICPT), whose share fell 2.14% to $63.35 in after-hours trading on Thursday. Warnings about the safety of Ocaliva due to incorrect dosing started emerging in the fall of 2017.

To ensure correct dosing and reduce the risk of liver problems, the FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. The FDA is adding a new Boxed Warning, the agency’s most prominent warning, to highlight this information in the prescribing information of the drug label. The FDA is also requiring a Medication Guide for patients to inform them about this issue.