OCALIVA: New Drug Trials Snapshot Posted

A new DRUG TRIALS SNAPSHOT FOR OCALIVA is now available.

OCALIVA is a drug for the treatment of primary biliary cholangitis (PBC) in adults. OCALIVA is to be used

• with another drug called ursodeoxycholic acid in patients whose liver enzyme tests do not adequately improve after using ursodeoxycholic acid for an appropriate period of time,

or

• on its own when patients cannot take ursodeoxycholic acid because of side effects.

Primary biliary cholangitis is an autoimmune disease that causes the small bile ducts in the liver to become inflamed, damaged and destroyed. This may lead to liver failure, cirrhosis and death.

Drug Trials Snapshots provide information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.

See more Drug Trial Snapshots or contact us with questions at Snapshots@fda.hhs.gov.