Overview
- The European Medicines Agency’s CHMP recommended on Friday that the EU marketing authorisation for Tavneos (avacopan) be revoked because the pivotal ADVOCATE trial can no longer be relied on to prove efficacy.
- CHMP concluded the ADVOCATE study was conducted in breach of good clinical practice, including cases where unblinded staff reselected and readjudicated patients, and said those data were incorrect and misleading.
- Postmarketing surveillance has identified dozens of serious drug‑induced liver injury cases and instances of vanishing bile duct syndrome, including fatal outcomes, with most events occurring in the first three months of treatment.
- The committee advised that no new patients start Tavneos, that current patients be switched to suitable alternatives, and that liver tests be done at least every two weeks for patients treated under three months and every four weeks for those treated longer until six months.
- CHMP’s opinion will be sent to the European Commission for a final legally binding decision and follows parallel U.S. concerns, where the FDA has urged withdrawal while the manufacturer has commissioned an independent review.