Key facts
- FDA proposed withdrawing Tavneos approval due to alleged data manipulation and serious liver injury reports.
- Tavneos was approved in October 2021 based on a narrow advisory committee recommendation.
- Amgen acquired ChemoCentryx, the drug's developer, a year after its approval.
- Tavneos generated nearly $500 million in sales in fiscal year 2025.
- The New England Journal of Medicine retracted a paper on the drug's clinical trial.
- The UK and EU have announced plans to remove Tavneos from their markets.
The US Food and Drug Administration is seeking to withdraw its approval for the drug Tavneos, citing concerns over manipulated data in its pivotal trial and reports of serious liver injury. The drug, used to treat a rare autoimmune form of vasculitis, was approved in October 2021, following a narrow recommendation from an advisory committee. Amgen, which acquired ChemoCentryx, the drug's developer, argues that the totality of evidence supports Tavneos's continued availability, a stance echoed by some patients and experts.