Amgen Files Update to Tavneos Label as FDA Escalates Push to Withdraw

FDA Proposes Withdrawal of Amgen's Tavneos Over Clinical Trial Data Integrity Issues

The FDA is proposing the withdrawal of avacopan (Tavneos), a medication used for vasculitis, following revelations of serious data integrity violations during its pivotal clinical trial. According to the FDA’s Center for Drug Evaluation and Research (CDER), unblinded study personnel manipulated the trial’s results to make the drug appear effective when the original analysis failed to meet primary endpoints. The manufacturer, ChemoCentryx (subseq…

Amgen files update to Tavneos label as FDA escalates push to withdraw

Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...