BRIEF---EMA recommends revoking conditional authorization for Ocaliva
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorization be revoked, because its benefits are no longer considered to outweigh its risks.
Ocaliva is used to treat adults with primary biliary cholangitis (PBC), an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.
Intercept was acquired by Italy-based Alfasigma last year for around $800 million.
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