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Intercept updates Ocaliva label after reports of liver function decline, failure

Intercept Pharmaceuticals, Inc. updated the prescribing information for its drug Ocaliva in the U.S. after a decline in liver function and failure were reported in patients with advanced cirrhosis when the drug was taken more frequently than the recommended starting dosage.

The company made the change to reinforce appropriate dosing in primary biliary cholangitis patients with Child-Pugh class B or C or decompensated cirrhosis.

Primary biliary cholangitis, or PBC, is a rare, autoimmune disease that results in a slow, progressive destruction of the small bile ducts of the liver, causing bile and other toxins to build up in the liver, a condition called cholestasis. The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis.

Cirrhosis is a late stage of scarring of the liver, while decompensated cirrhosis means that the liver is extensively scarred and unable to function properly.

Intercept revised the drug's label to include a boxed warning and a dosing table that reinforce the existing dosing schedule for such patients.

Previously, the U.S. Food and Drug Administration had issued a warning to Intercept Pharmaceuticals noting that incorrect dosage of the drug was leading to increased risk of serious liver injury and death in patients.

The FDA identified 19 deaths with Ocaliva use. The cause of death in seven cases was reported to be worsening of PBC, with cardiovascular disease cited in one case.

The NY-based biotechnology company responded to the FDA stating that it will take necessary action to ensure the safe use of its liver disease drug Ocaliva.

Intercept is also working with the European Medicines Agency to ensure appropriate dosing in patients with advanced cirrhosis. The drug was approved in Europe in December 2016 as a treatment for PBC.