Avacopan approval for ANCA associated vasculitis under review
In quite startling news, the US FDA Center for Drug Evaluation and Research (CDER) and European Medicines Agency (EMA) are reviewing the approval of Avacopan for the treatment of GPA and MPA. The CDER has reported that patient outcomes in the ADVOCATE trial were re-adjudicated after unblinding and that the original data which was not supplied to the FDA would not have shown superiority over the placebo arm. In addition there have been rare cases of drug induced liver injury including vanishing bile duct syndrome in association with Avacopan, calling into question the risk/benefit profile of the medication. Links to the relevant press releases below:
https://www.fda.gov/drugs/drug-alerts-and-statements/cder-proposes-withdraw-approval-tavneos
https://www.fda.gov/media/192160/download
