European regulators have opened a review of Amgen’s Tavneos (avacopan) after new information raised questions about the integrity of the Advocate trial data that supported the drug’s initial approval. The EMA said concerns relate to how the study data were handled, which could have influenced effectiveness findings. The agency’s move does not equate to a safety recall but initiates a focused review that could lead to label changes, additional analyses, or other regulatory actions depending on outcomes. Amgen will be required to respond to EMA requests as the review proceeds.