NEJM retracts study behind Amgen's Tavneos approval after FDA finds altered data
The New England Journal of Medicine has retracted an article on the pivotal clinical trial that underpinned the approval of Tavneos, a rare-disease drug made by Amgen (AMGN), after US regulators found evidence that patient outcome data had been altered.
Two academic authors of the 2021 study requested the retraction after an investigation by the Food and Drug Administration found that results for nine patients had been changed and that some researchers had been told which patients received Tavneos and which had not. The journal said the changes were not disclosed in the original article.
An Amgen spokesperson said the company took scientific integrity seriously and respected the role of journals in upholding the peer review process. The results of a re-adjudication of the trial data by the Duke Clinical Research Institute would be shared with the FDA as part of a hearing submission due by July 29 and would also be submitted for publication, the spokesperson added. Tavneos remains on the US market.
The retraction adds to mounting regulatory pressure on the drug. In April, the FDA's Center for Drug Evaluation and Research proposed withdrawing Tavneos' approval, citing a lack of proven effectiveness and false statements in the original application. In March, the agency identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to the drug, including seven cases of vanishing bile duct syndrome, a rare condition that can cause permanent liver damage. Eight deaths were reported among those cases.
Tavneos was approved in October 2021 to treat severe active ANCA-associated vasculitis, a rare disease that inflames small blood vessels and can damage organs including the kidneys and lungs.
Europe's medicines regulator also recommended revoking the drug's marketing authorization, citing concerns over the integrity of its trial data. Amgen has engaged an outside research firm to independently review the Tavneos data as it seeks to defend the drug's benefits ahead of its hearing with the FDA.