The prestigious medical journal “The New England Journal of Medicine” (NEJM) has retracted a paper published in 2021 regarding a pivotal clinical trial of Amgen’s rare-disease drug Tavneos (avacopan). This decision follows an investigation by the U.S. Food and Drug Administration (FDA), which revealed that patient data had been altered and the trial’s blinding protocol had been compromised for some investigators during the study.
The retraction was requested by two academic authors of the study after it was discovered that the primary outcomes of nine patients were re-evaluated after the database lock and following a breach of the study’s blinded regime. The journal’s editorial board emphasized that these modifications were not disclosed in the original paper, which is entirely inconsistent with proper scientific ethics and the regulations governing clinical trials.
This development further escalates the ongoing tension between Amgen and the regulatory authority, who have been locked in a sharp legal dispute for several months. In April of this year, the FDA’s Center for Drug Evaluation and Research (CDER) formally proposed a full withdrawal of Tavneos’ approval from the market. The agency stated that new information, which came to light only three years after the drug’s authorization, showed that trial personnel manipulated clinical outcomes to make the drug appear effective, whereas the original objective analysis did not support that conclusion at all. The regulator concluded that it is currently impossible to claim that the drug’s efficacy was ever validly established.
In addition to allegations of data manipulation, serious safety risks have also emerged surrounding the medication. In March, the FDA reported 76 cases of severe liver injury potentially linked to the use of Tavneos, eight of which were fatal. Similar steps were taken in Europe, where the regional regulatory body also withdrew its backing for the drug, and its local distributor announced that the medication would no longer be prescribed to new patients.
Tavneos was originally approved in 2021 by ChemoCentryx, which Amgen acquired in 2022 for $3.7 billion, and the drug generated $459 million in revenue for the company last year. Amgen representatives state that they hold scientific integrity to the highest standard and remain confident in the drug’s safety. The company has already requested a formal hearing with the FDA and has hired the Duke Clinical Research Institute to conduct an independent re-analysis, the results of which will be submitted to the regulator by the end of July.
