Avacopan's EU Approval Revoked Amid Data Integrity Concerns
The European Medicines Agency (EMA) has published its full scientific rationale behind the withdrawal of avacopan from the EU market. The agency's Article 20 Public Assessment Report explains how nine altered patient records, changed after a trial's database was sealed and treatment assignments were revealed, destroyed the evidentiary foundation of the $459 million drug approval.
The assessment report details a sequence of events that led to the withdrawal of avacopan (Tavneos) across all EU member states and the European Economic Area. The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended revocation on June 25, 2026.
The same data-integrity failure that ended avacopan's four-year European run is also the basis for the FDA's proposal to withdraw Tavneos, issued April 27, 2026. Amgen has submitted a formal hearing to the FDA and presented re-adjudication data from an independent review.
The EMA concluded that a company-sponsored independent re-analysis cannot repair a GCP violation, which may preview the outcome of the US hearing. The report highlights the importance of maintaining a database lock in clinical trials, where data collection is formally declared complete and access to the data is sealed.