The European Medicines Agency (EMA) moved to revoke marketing authorization for Amgen and Vifor’s complement inhibitor Tavneos (avacopan) after concluding the approval basis relied on “incorrect and misleading” data. The EMA’s committee recommendation follows a review that began in January after concerns were raised about data integrity in the Advocate trial supporting the EU marketing authorization. A separate EMA story also reports that the CHMP is aligning with the FDA, with both regulators citing data integrity concerns and recommending withdrawal. In Europe, Tavneos is used for two rare and severe vasculitis conditions—active granulomatosis with polyangiitis and microscopic polyangiitis. Amgen is now facing diverging trajectories across regulators: the EMA’s recommendation sets the stage for potential EU withdrawal, while the FDA has also previously proposed action that could lead to a US market exit.