June 29 (Reuters) – 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 U.S. 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.
Amgen, which has previously said it remains confident in Tavneos’ benefit-risk profile, did not immediately respond to a Reuters request for comment.
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.
(Reporting by Puyaan Singh in Bengaluru; Editing by Sahal Muhammed)
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