The European Medicines Agency’s committee recommended withdrawing Amgen’s Tavneos (avacopan) from the European market, citing “incorrect and misleading” data provided during the marketing authorization assessment. The EMA said the submission materials could no longer be relied on to demonstrate Tavneos’ effectiveness after a review that began in January. The EMA’s stance follows parallel skepticism inside the US regulatory process, where the FDA’s Center for Drug Evaluation and Research recommended withdrawal earlier this year. In Europe, the move escalates a controversy that has already triggered additional scrutiny of the underlying Advocate study data. For Amgen and CSL’s European marketing footprint, the recommendation creates immediate planning pressure around patient access, label expectations, and downstream litigation or settlement strategy. It also highlights how data integrity issues can quickly override prior benefit-risk conclusions for complement inhibition therapies. Amgen will likely need to navigate a fast-moving European pathway while the FDA process continues in parallel, reinforcing that post-approval data disputes can become a major operational and commercial risk even for established regulatory approvals.