Given these findings, the prescribing information was updated to state Ocaliva was contraindicated in PBC patients with advanced cirrhosis of the liver. Since then additional postmarket clinical data have identified cases of serious liver injury among PBC patients without cirrhosis of the liver. Notably, these cases revealed that among this population, the risk of liver transplant and/or death was higher in those treated with Ocaliva vs those receiving placebo. Additionally, despite the updated limitations, case reports showed PBC patients with advanced cirrhosis were still receiving Ocaliva. Alongside the withdrawal request, the FDA has also placed a clinical hold on all Intercept clinical trials involving obeticholic acid. "We continue to believe the totality of clinical and real-world evidence supports Ocaliva's use for appropriate patients, and we are proud of the contribution Ocaliva has made in advancing care for people living with PBC ," said Vivek Devaraj, US President at Intercept.