The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the marketing authorization for Amgen’s Tavneos (avacopan). The committee concluded the drug's benefits no longer outweigh its risks for treating rare autoimmune blood vessel diseases.
Regulators found the pivotal ADVOCATE study breached good clinical practice standards. The panel determined the study data was incorrect and misleading, making it unreliable for demonstrating the drug's effectiveness.
This recommendation follows a similar U.S. FDA proposal to withdraw the drug due to safety concerns, including liver injury.
The EMA panel advised that no new patients should start the therapy. Current patients should transition to alternative treatments. The European Commission will now review the recommendation to issue a final, legally binding decision.