European Commission Revokes Marketing Authorization for Ocaliva, a Liver Disease Drug, Amid Regulatory Dispute
Revocation Decision:
The European Commission has revoked the conditional marketing authorization for Ocaliva, a drug used to treat primary biliary cholangitis (PBC), a rare liver disease14.
Immediate Effect:
The revocation is effective immediately, impacting thousands of patients who were benefiting from the drug14.
Temporary Suspension Lifted:
The revocation follows a temporary suspension of the decision, which was previously secured by Advanz Pharma but has now been lifted24.
Disagreement and Next Steps:
Advanz Pharma disagrees with the decision and is considering next steps to support patients with PBC13.
Regulatory Back-and-Forth:
The revocation is the result of a regulatory back-and-forth between Advanz Pharma and the European Commission, highlighting the challenges in maintaining drug authorizations45.
Sources:
1. https://www.advanzpharma.com/news/2024/advanz-pharmas-response-to-the-reversal-of-the-suspension-of-the-european-commission-decision-on-the-ocaliva-conditional-marketing-authorisation-in-europe
2. https://www.advanzpharma.com/news/2024/advanz-pharma-secures-temporary-suspension-of-the-european-commission-decision-on-the-ocaliva-conditional-marketing-authorisation-in-europe
3. https://www.advanzpharma.com/news/2024/advanz-pharmas-response-to-european-commission-revocation-of-conditional-marketing-authorisation-for-ocaliva-in-rare-disease-primary-biliary-cholangitis-pbc
4. https://www.fiercepharma.com/pharma/after-temporary-reprieve-intercepts-liver-med-ocaliva-loses-marketing-nod-europe