FDA proposes withdrawing Tavneos approval in the US — Ars Technica
In the United States, the Food and Drug Administration (FDA) in April 2026 proposed withdrawing approval of Tavneos for the treatment of a rare form of autoimmune vasculitis. The regulator cited reports of severe, sometimes fatal liver injuries and said the drug no longer has sufficient evidence of effectiveness, Ars Technica reports.
Concerns about trial data
The FDA believes that employees of ChemoCentryx, which conducted the pivotal Tavneos trial, selected several patients for a reassessment of remission after unblinding data showing which participants had received the drug or a placebo. According to the agency, this violated the trial protocol, and the company did not inform the regulator either about the initial results or the reassessment.
The drug was approved on October 7, 2021, for patients with ANCA-associated vasculitis — a group of diseases in which the immune system attacks blood vessels and can damage the kidneys and lungs. Tavneos was intended to reduce the need for steroids, which are effective but can cause serious side effects. A year after the approval, Amgen acquired ChemoCentryx for nearly $4 billion.
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Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research, said that after the drug entered the market, it was linked to eight deaths and dozens of hospitalizations. This summer, the New England Journal of Medicine retracted an article on the Tavneos clinical trial at the request of two academic authors. The drug has already been withdrawn from the market in the European Union, and the United Kingdom has also announced its intention to remove it.
Amgen’s position and the FDA procedure
Amgen disagrees with the conclusions that Tavneos should be removed. In a 104-page document submitted to the FDA, the company said that the data reassessment conducted by ChemoCentryx in 2019 was intended to correct a small number of errors and that no clinical data were changed. At the same time, Amgen said that the previous company’s actions would not have aligned with its own approach and that information about the reassessment was not disclosed to the FDA.
The company also cites an independent reassessment of the trial at the Duke Clinical Research Institute and real-world medical practice data which, in its view, indicate the possibility of reducing steroid use. The FDA must provide the manufacturer with notice and an opportunity for a public hearing. After that, the agency may permanently withdraw the approval, and Amgen will have the opportunity to challenge the decision in court.
