NEJM retracts key Tavneos trial paper, deepening Amgen’s FDA fight
NEJM pulled the pivotal Tavneos paper after FDA findings that endpoint data were changed in nine patients and some researchers were unblinded. The retraction intensifies pressure on Amgen as regulators move against the drug in the U.S. and Europe.
The New England Journal of Medicine retracted the paper that underpinned Tavneos’s approval after an FDA investigation found that endpoint assessments in nine patients were readjudicated after database lock and trial unblinding.
The original article, published on February 18, 2021, was titled “Avacopan for the Treatment of ANCA-Associated Vasculitis.” It concluded that avacopan was noninferior to prednisone taper for remission at week 26 and superior for sustained remission at week 52 in adults with severe active ANCA-associated vasculitis. The FDA approved Tavneos on October 7, 2021, for use with glucocorticoids and other standard-of-care medications in adults with severe active disease, including granulomatosis with polyangiitis and microscopic polyangiitis.
In April, the FDA moved to withdraw the approval after determining that new information showed Tavneos had not been shown effective for its approved use and that the application contained untrue statements of material fact. In its April 30, 2026 notice, the FDA found that unblinded study personnel manipulated the pivotal trial results so the drug appeared effective, while the original analysis did not support that conclusion. The agency issued a notice of opportunity for a hearing to ChemoCentryx, Amgen’s wholly owned subsidiary.
In a March 31, 2026 safety communication, the FDA identified 76 cases of drug-induced liver injury linked to Tavneos through October 2024, including hospitalizations and deaths. The FDA has identified serious liver injury risks, including vanishing bile duct syndrome and fatal cases.
On June 26, 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended revoking Tavneos’s EU marketing authorization after an Article 20 non-pharmacovigilance review tied to data-handling concerns in the pivotal ADVOCATE trial. If the European Commission confirms the opinion, Tavneos will no longer be authorized in the European Union and European Economic Area. CSL, which commercializes Tavneos outside the U.S. in some markets, will not treat new patients with the drug there if that happens.
Amgen bought ChemoCentryx in 2022 for $3.7 billion, betting on a medicine that generated $462 million in sales in 2025 and $119 million in the first quarter of 2026, down 22% sequentially. As the FDA hearing approaches, Amgen has hired the Duke Clinical Research Institute to independently review Tavneos data.
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