Ocaliva (obeticholic acid) has been approved by the U.S. Food and Drug Administration to treat a rare chronic liver disease called primary biliary cholangitis (PBC).
The disease causes the liver’s small bile ducts to become inflamed, ultimately destroying the ducts and leading to cirrhosis, which is scarring of the liver. Over time, this leads to a potentially deadly loss of liver function, the agency said Tuesday in a news release.
Ocaliva is designed to increase bile flow from the liver. The drug was evaluated in clinical studies involving 216 people, and the most commonly recorded side effects included itchy skin, fatigue, abdominal pain, throat pain, dizziness and constipation.
Ocaliva should not be given to people whose bile ducts are completely blocked, the FDA warned.
Clinical studies have not established an improvement in survival, progression to liver scarring or suppression of disease-related symptoms, the agency said, noting that clinical trials evaluating these factors are ongoing.
Ocaliva is produced by New York City-based Intercept Pharmaceuticals.
To learn more about PBC, visit the American Liver Foundation.