EU Court halts Commission's ban on drug for rare liver disease - Yahoo News UK
Obeticholic acid (Ocaliva) faces EU ban for lack of benefit in early-stage PBC, but Advanz Pharma secured a temporary suspension of the ban. Patients protest, highlighting the drug's critical role when initial treatments fail.
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Advanz Pharma secured a temporary suspension of the European Commission's decision to revoke Ocaliva's conditional approval for primary biliary cholangitis (PBC), ensuring its availability in the EU, Iceland, Liechtenstein, and Norway. Advanz disagrees with the EC's decision, citing real-world data and trial results supporting Ocaliva's benefits. The U.S. FDA is reviewing Intercept Pharmaceuticals' application for full approval, with a decision expected in October.
Obeticholic acid (Ocaliva) faces EU ban for lack of benefit in early-stage PBC, but Advanz Pharma secured a temporary suspension of the ban. Patients protest, highlighting the drug's critical role when initial treatments fail.