Europe’s drug regulator moved closer to pulling Tavneos (avacopan) after the CHMP joined the FDA in challenging the approval basis for Amgen and Vifor’s rare-disease treatment. The recommendation to revoke EU authorization cites data integrity concerns tied to the Advocate study used to support the marketing application. In parallel, the EMA’s committee recommended withdrawing Tavneos in light of “incorrect and misleading” data, and the FDA has outlined a U.S. withdrawal proposal that is expected to proceed to a hearing. The coordinated escalation underscores how clinical dataset validity—beyond trial outcomes—can determine the fate of late-stage biologics and small molecules. For stakeholders, the next steps are decisive: EU deliberations on revocation and U.S. procedural milestones (including the hearing) will shape whether Tavneos exits both markets or survives via additional agency-specific justification.