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Intercept's Ocaliva Seems Headed For Black Box On Liver Injury Risk

 
• By Joseph Haas

Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.

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In the aftermath of a “Dear Healthcare Provider Letter” and an FDA Drug Safety Communication related to its primary biliary cholangitis (PBC) drug Ocaliva, Intercept Pharmaceuticals Inc. is working with the US agency to update the label, better educate physicians on proper dosing of the bile acid synthesis inhibitor, and determine if the drug was related to five serious hepatic adverse events reported in patients with less advanced PBC.

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