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European Commission gives conditional approval to Intercept's liver disease drug

The European Commission granted conditional approval to Intercept Pharmaceuticals Inc.'s Ocaliva for the treatment of primary biliary cholangitis, a rare autoimmune cholestatic liver disease.

The drug will be used in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid.

The marketing authorization will enable Intercept Pharmaceuticals to market the drug in 28 member states of the EU and three additional European Economic Area member states.

As conditions of the approval, the company is required to provide post-approval updates on safety and efficacy analyses for Ocaliva from the ongoing phase 4 outcomes study and a short-term study in patients with hepatic impairment.