Amgen Inc. has retained the Duke Clinical Research Institute to conduct a fresh review of the clinical trial results that underpinned regulatory approval of Tavneos, the company said in a letter dated June 1 and posted online Thursday. The independent reanalysis began in February, according to the same letter.
The move follows an action by the U.S. Food and Drug Administration in which the agency proposed withdrawing approval for Tavneos amid allegations that data submitted to the FDA by the drug's prior manufacturer were manipulated. The scientific journal that originally published the trial findings is also pursuing an inquiry into the same allegations.
In its communication, Amgen said it intends to include the Duke review in a package of materials to be submitted to the FDA by June 29. The company expressed the view that, for patients with the rare disease the drug treats, Tavneos' benefits outweigh its risks and that withdrawing approval would not serve patients' best interests nor align with the statutory criteria for regulatory withdrawal.
Tavneos was acquired by Amgen through its $3.7 billion purchase of ChemoCentryx in 2022. The drug currently brings in roughly $500 million in annual sales and is indicated for treatment of ANCA-associated vasculitis, a rare autoimmune condition that causes inflammation of small blood vessels and can lead to severe kidney and lung damage.
The FDA has previously commented that a new independent analysis of the trial data would not be statistically appropriate and would not "redeem" the original study. That view stands alongside the agency's proposed withdrawal and the ongoing investigation by the journal that published the initial trial report.
Context and next steps
Amgen's submission of the Duke review by June 29 will form part of the materials the company presents to the FDA for consideration. The timeline and the competing views - Amgen's assertion of benefit versus the FDA's prior statement questioning the value of a new analysis - outline the procedural questions to be resolved in the coming weeks.
Patient and market implications
The outcome of this review and the FDA's response will affect patients reliant on Tavneos for management of ANCA-associated vasculitis and may have implications for Amgen's revenue stream tied to the drug's roughly $500 million in annual sales.