Intercept Pharmaceuticals Inc. announces updates to Ocaliva prescribing information for primary biliary cholangitis

Intercept Pharmaceuticals, Inc. announced that the Ocaliva (obeticholic acid or OCA) Prescribing Information in the United States has been updated.The changes to the Ocaliva Prescribing Information were prompted by cases submitted to FDA’s Adverse Event Reporting System and published in the medical literature describing cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva. Because of this, the Boxed Warning has been updated and Ocaliva is now contraindicated for patients with PBC and decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis with evidence of portal hypertension.

“Cirrhosis exists on a continuum with escalating levels of underlying risk as patients progress from compensated to decompensated cirrhosis, and development of portal hypertension is a pivotal step in the progression of the disease that is associated with an increased risk of negative outcomes,” said Gail Cawkwell, M.D., Ph.D., Acting Chief Medical Officer of Intercept. “These new updates to the Ocaliva Prescribing Information include important additional warnings and precautions to help health care professionals identify patients with PBC and cirrhosis who may be at risk of experiencing liver-related side effects and manage their liver health. They do not change Ocaliva treatment guidance for the large majority of people living with PBC, as most patients with PBC do not have decompensated cirrhosis, a prior decompensation event, or compensated cirrhosis with evidence of portal hypertension. Ocaliva remains the only FDA-approved second line therapy for the treatment of this rare disease and has the potential to help patients before their disease has progressed to the advanced stage of cirrhosis.”.