EMA Recommends Revocation of Market Authorization for Tavneos Due to Data Integrity Issues

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended revoking the market authorization for Tavneos (avacopan), a medicine used to treat two inflammatory conditions in blood vessels. The decision stems from findings that data provided from its pivotal 'Advocate' study were incorrect and misleading, breaching good clinical practice (GCP) principles. CSL Vifor, the licensee in Europe, has announced it will stop all new patient initiations for Tavneos in markets under EMA's jurisdiction.