EU Revokes Tavneos Marketing Authorization Over Serious GCP Breaches

The European Commission recently revoked marketing authorization for Tavneos (avacopan) due to 'serious breaches' of Good Clinical Practice in a pivotal Phase III trial. The EU's CHMP concluded that these breaches invalidated the benefit-risk assessment, leading to revocation. This raises questions about what the FDA knew during its parallel review and why it didn't take action.

Tavneos was developed by ChemoCentryx, acquired by Amgen in 2022, with CSL Vifor holding European marketing rights. The FDA approved avacopan on October 7, 2021, as an add-on treatment for adults with severe active ANCA-associated vasculitis, while the EMA followed suit on January 11, 2022.

The ADVOCATE trial failed during execution, not at approval. GCP breaches are site-level events that can be invisible until it's too late. Someone at ChemoCentryx or its CRO must have signed off on monitoring reports and data management outputs without detecting these deviations.