Amgen formally submitted new data and analyses to the U.S. Food and Drug Administration (FDA) on July 23, 2026. The company announced the filing on July 24 to challenge the agency's proposal to withdraw its rare-disease drug, Tavneos. Amgen is also requesting a formal hearing to dispute the FDA's claims.
The FDA proposed withdrawing Tavneos in April 2026. Regulators cited concerns regarding data integrity in the original pivotal trial and risks of liver toxicity. Tavneos is currently used to treat ANCA-associated vasculitis, a rare autoimmune disorder.
Amgen’s submission includes an independent, blinded re-adjudication of the trial's primary outcomes. The Duke Clinical Research Institute conducted this new analysis. Amgen maintains the evidence supports a favorable benefit-risk profile for the medication.