GoKawiilFDA moves to withdraw Amgen's Tavneos over alleged trial data manipulation
The FDA approved ChemoCentryx's vasculitis drug Tavneos in October 2021 after a narrow advisory committee vote, despite concerns that the pivotal trial's design made its benefits hard to verify. Amgen acquired ChemoCentryx a year later, and Tavneos has since generated nearly $500 million in annual sales at roughly $220,000 per patient per year. In April 2025, the FDA proposed withdrawing the drug, citing reports of serious liver injury and evidence—surfaced through an investor lawsuit—that ChemoCentryx employees may have manipulated trial data submitted to regulators.