September is shaping up to be a make-or-break month for Intercept Pharmaceuticals, Inc. and Advanz Pharma Corp.’s approved liver disease drug Ocaliva (obeticholic acid) in the EU and US.
Key Takeaways
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The European Commission has revoked Advanz's conditional marketing authorization for Ocaliva, for treating PBC, after EU regulators decided that the drug's clinical benefits had not been confirmed.
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In the US, Intercept will defend the drug before the Gastrointestinal Drugs Advisory Committee, which could be asked whether the PBC indication should be withdrawn if clinical benefit has not been demonstrated
The European Commission has revoked the drug’s conditional marketing authorization for treating primary biliary cholangitis (PBC) following a recommendation to do so from the European Medicines Agency’s human
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