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# Intercept Withdraws Ocaliva Amid Liver Safety Concerns
- URL: https://www.fdaweb.com/intercept-withdraws-ocaliva-amid-liver-safety-concerns/
- Published: 2025-09-11T12:00:00.000Z
- Updated: 2026-09-14T15:21:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159849

Intercept Pharmaceuticals says it is withdrawing Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis (PBC), following an FDA request that cited liver injury concerns. Last December, FDA issued a [drug safety communication](https://www.fda.gov/drugs/drug-safety-and-availability/serious-liver-injury-being-observed-patients-without-cirrhosis-taking-ocaliva-obeticholic-acid-treat?utm%5Fmedium=email&utm%5Fsource=govdelivery), saying its review of postmarket clinical trial data identified cases of serious liver injury in patients being treated for PBC with Ocaliva. “FDA’s review of this required clinical trial found that some cases of liver injury in patients without cirrhosis resulted in liver transplant,” the notice said at the time. “This risk was notably higher for patients taking Ocaliva compared with a placebo….”

Ocaliva, a farnesoid X receptor agonist, received accelerated approval in 2016 for adults with PBC who had an inadequate response to or could not tolerate ursodeoxycholic acid. “While our view of Ocaliva’s benefit-risk profile differs from FDA’s, we respect its request and have made this difficult decision,” a company statement says. 

Additionally, the agency placed a clinical hold on all Intercept clinical trials conducted under an IND involving obeticholic acid.