OCALIVA received a Notice of Compliance with Conditions in May 2017 for the treatment of PBC, pending the results of trials to verify its clinical benefit. OCALIVA is now contraindicated for PBC patients with advanced disease, such as those with Child-Pugh Class B or C decompensated cirrhosis or a prior decompensation event, as well as for patients with compensated cirrhosis who have evidence of portal hypertension. This change is based on the frailty of and the inability to complete studies to verify its clinical benefits in these patients, as well as available safety data from post-marketing reports.
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