The EMA recommended withdrawing marketing authorization for Amgen’s Tavneos (avacopan) after concluding that data underpinning the original approval were “incorrect and misleading” and could no longer be relied upon to demonstrate effectiveness. The agency cited concerns over data integrity tied to the Advocate study used for the MAA assessment. The EMA’s position follows an April recommendation from the FDA’s Center for Drug Evaluation and Research to withdraw Tavneos from the US. Separate regulatory processes are now aligned around the same core problem: the evidentiary basis for effectiveness. For Amgen and partners in complement inhibition, the EMA step intensifies commercial and clinical disruption risk, including potential product-market withdrawals across Europe while the company challenges the basis for the decision. The decision also raises broader compliance attention across regulatory submissions relying on contested datasets.