The FDA has declined to grant full approval to obeticholic acid (Ocaliva, Intercept) for the treatment of adults with primary biliary cholangitis.
However, the medication will continue to be available to patients under its accelerated approval status, which was granted in 2016. Under its current status, obeticholic acid is indicated in combination with ursodeoxycholic acid (UDCA) in adults with PBC who had an inadequate response to UDCA or as monotherapy in those who are unable to tolerate