The conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) for the rare autoimmune disease primary biliary cholangitis (PBC) has been revoked in the EU and the European Economic Area (EEA) after a decision by the General Court of the European Union.
Advanz Pharma’s Ocaliva Loses EU Conditional Marketing Authorization
Advanz Pharma, the company that markets Ocaliva for primary biliary cholangitis in the EU, will continue to supply the drug on a compassionate use or named patient basis.
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