New medicine for rare, chronic liver disease Ocaliva recommended for conditional approval
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) to Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis (also known as primary biliary cirrhosis). Ocaliva is to be used in combination with another medicine, ursodeoxycholic acid (UDCA), in patients who have not responded adequately to UDCA, or on its own in adults who are unable to tolerate treatment with UDCA.
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