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EU, US Move to Pull Amgen's Tavneos Over Liver Injuries

6/27/2026

Summary

Story summary

The European Union's EMA recommended revoking Amgen's Tavneos (avacopan) marketing authorisation in the EU.
The U.S. FDA also proposed withdrawal after reporting 76 drug-induced liver injury cases linked to Tavneos.
The EMA said the ADVOCATE trial data were incorrect, misleading and breached good clinical practice, preventing proof of efficacy.
Amgen hired an independent reviewer and extended its FDA data submission deadline to July 29 from June 29.

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Story summary

The European Union's EMA recommended revoking Amgen's Tavneos (avacopan) marketing authorisation in the EU.
The U.S. FDA also proposed withdrawal after reporting 76 drug-induced liver injury cases linked to Tavneos.
The EMA said the ADVOCATE trial data were incorrect, misleading and breached good clinical practice, preventing proof of efficacy.
Amgen hired an independent reviewer and extended its FDA data submission deadline to July 29 from June 29.