FDA advisory committee to recommend approval of primary biliary cholangitis treatment drug: 4 takeaways

The FDA's Gastrointestinal Drugs Advisory Committee voted unanimously to recommend accelerated approval of Intercept Pharmaceuticals' Ocaliva.

Here are four takeaways:

1. Ocaliva (obeticholic acid) is intended for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis.

2. The drug is specifically intended for the treatment of PBC in patients with an inadequate response to, or who are unable to tolerate, ursodeoxycholic acid.

3. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

4. The FDA is not bound by the advisory committee's guidance, but takes its advice into consideration.