EU revokes marketing authorisation for CSL-partnered TAVNEOS in EU, EEA

PUBT · 2d ago
EU revokes marketing authorisation for CSL-partnered TAVNEOS in EU, EEA
  • EU regulators revoked the marketing authorization for TAVNEOS (avacopan), removing it from prescribing across the EU and EEA.
  • The European Commission adopted the decision on Aug. 6, 2026, following an EMA CHMP recommendation dated June 26, 2026.
  • The action followed an Article 20 non-pharmacovigilance review triggered by concerns over data handling in the Phase 3 ADVOCATE trial.
  • CHMP concluded a positive benefit-risk balance could no longer be established, forcing a managed discontinuation with national authorities.


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