The Medical Letter on Drugs and Therapeutics
Obeticholic Acid (Ocaliva) for Primary Biliary Cholangitis
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Revised 1/26/18: See Dosage and Administration third paragraph.

Obeticholic acid (Ocaliva – Intercept), a farnesoid X receptor agonist, has been approved by the FDA for treatment of primary biliary cholangitis; it is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in adults with an inadequate response to UDCA and as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is the second drug to be approved for this indication; UDCA was the first.

PRIMARY BILIARY CHOLANGITIS — Primary biliary cholangitis, formerly called primary biliary cirrhosis, is a rare progressive autoimmune disease of the intralobular bile ducts that can lead to fibrosis, cirrhosis, and liver failure.1 It most commonly affects women >40 years old.

STANDARD TREATMENT — UDCA, a naturally occurring hydrophilic bile acid, replaces toxic hydrophobic bile acids that accumulate ... more      

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