The EMA has joined the FDA in moving toward withdrawal of Amgen’s Tavneos (avacopan) after both agencies flagged data integrity problems. A CHMP review recommended revoking the drug’s EU marketing authorization, citing that the original assessment relied on “incorrect and misleading” data that can no longer be used to demonstrate effectiveness. The EMA’s action follows an earlier FDA proposal to withdraw Tavneos from the U.S. market and an FDA concern focused on the Advocate trial package. Together, the parallel moves underscore how post-approval scrutiny can rapidly unwind rare-disease product access. For biotech operators and partners, the case is a high-signal reminder that dossier accuracy and study documentation can become the gating issue—more than trial outcomes—once regulators question the reliability of the underlying record.