Overview
Amgen Inc. announced that it has engaged the Duke Clinical Research Institute to conduct a fresh evaluation of the clinical data supporting its rare‑disease drug Tavneos, following a U.S. Food and Drug Administration (FDA) proposal to withdraw the product’s approval.
Background
Tavneos, indicated for ANCA‑associated vasculitis, was acquired by Amgen in its 2022 purchase of ChemoCentryx for $3.7 billion. The drug currently generates approximately $500 million in annual sales. The FDA’s proposal to withdraw approval stems from allegations that data submitted by ChemoCentryx were manipulated; the medical journal that originally published the trial results is also investigating the claims.
Review Process
The independent review commenced in February 2026. Amgen posted a letter dated 1 June 2026 confirming the start of the re‑evaluation. Amgen intends to deliver the revised analysis to the FDA by 29 June 2026 as part of a broader submission package that it believes demonstrates that the benefits of Tavneos outweigh its risks for patients with the rare autoimmune condition.
Regulatory Position
The FDA has previously stated that a new independent analysis would not be statistically appropriate and would not “redeem” the original study. Amgen’s current approach seeks to address the agency’s concerns while maintaining that withdrawal would not serve patients’ best interests nor satisfy statutory criteria.
Expected Outcome
Amgen’s submission aims to retain Tavneos on the market, preserving the $500 million revenue stream and continued treatment options for patients with ANCA‑associated vasculitis.