Drug Trial Data Manipulation Wiped Avacopan’s EU Approval as FDA Hearing Looms
The EMA published an Aug 6, 2026 assessment report detailing alleged manipulation of nine patient records in the ADVOCATE Phase 3 trial of avacopan (Tavneos), after database lock and unblinding. The European Commission revoked EU approval Aug 6, 2026, following a June 25 CHMP recommendation. In the US, the FDA is reviewing Amgen’s July 23 hearing submission to withdraw Tavneos, based on similar data-integrity issues.
