The European Medicines Agency (EMA) moved to revoke Amgen’s Tavneos (avacopan) after its Committee for Medicinal Products for Human Use (CHMP) concluded that the original approval basis used “incorrect and misleading” data that can no longer be relied upon for efficacy. The CHMP recommendation follows an EMA review that began in January amid concerns about the integrity of the data underlying the pivotal Advocate study. The development mirrors the FDA’s earlier stance, setting up additional scrutiny for the Tavneos label across markets. For Amgen and partner Vifor, the action escalates an already high-profile regulatory dispute and increases the near-term risk to revenue and patient access for the two rare vasculitis indications covered by Tavneos.