The New England Journal of Medicine on Monday retracted an article on a pivotal clinical trial that supported approval of Amgen’s rare-disease drug, citing concerns that patient outcome data were altered and that some researchers had been unblinded.
The journal said two academic authors of the 2021 study requested the retraction after a US Food and Drug Administration investigation found results for nine patients were altered and some researchers were told which patients received the drug, Tavneos, and who did not.
The changes were not disclosed in the article, said the journal.
An Amgen spokesperson said it “takes scientific integrity seriously and respects the role of journals in upholding the peer review process.”
They said results of a “re-adjudication” of the trial’s results by the Duke Clinical Research Institute “will be shared with the FDA as part of our hearing submission due by July 29 and submitted for publication. TAVNEOS remains on the market in the U.S.”
In April, the FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing Tavneos’ approval, citing a lack of proven effectiveness and false statements in its original application.
In March, the agency identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos, including seven cases of vanishing bile duct syndrome (VBDS), a rare condition that can cause permanent liver damage. Eight deaths were reported among those cases.
Tavneos was approved in October 2021 to treat a rare disease called severe active ANCA-associated vasculitis, which inflames small blood vessels and can damage organs like the kidneys and lungs.
Europe’s drug regulator last week also recommended revoking the marketing authorization for the drug, citing concerns over the integrity of its trial data.
Amgen has signed up a research firm to independently review the data on Tavneos, as it seeks to prove the drug’s benefits before a hearing with the FDA.
Source:
www.jpost.com
