Indications of Obeticholic

Obeticholic Acid Tablets (OCALIVA®) are indicated for the treatment of adult patients with primary biliary cholangitis (PBC), specifically including the following two groups of patients:

Patients without cirrhosis;

Patients with compensated cirrhosis but no evidence of portal hypertension.

This product can be administered in two ways: first, in combination with ursodeoxycholic acid (UDCA) for patients with an inadequate response to UDCA; second, as monotherapy for patients who are intolerant to UDCA.

This indication was approved under the accelerated approval program, based on the endpoint of reduced alkaline phosphatase (ALP) levels. At present, it has not been confirmed that this product can improve patient survival rate or relieve disease-related symptoms. The continued approval of this indication may be contingent upon the verification and demonstration of clinical benefits in subsequent confirmatory trials.

FDA，2022.02