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BioWorld - Tuesday, January 6, 2026
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Home » Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now
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Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now

Sep. 5, 2024
By Nuala Moran
Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.
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