The New England Journal of Medicine retracted an article on a pivotal clinical trial that supported approval of Amgen’s rare-disease drug, Tavneos, citing concerns that patient outcome data were altered and that some researchers had been unblinded.
Retraction Details
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 and who did not.
Amgen, which has previously said it remains confident in Tavneos’ benefit-risk profile, did not immediately respond to a request for comment. 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 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, a rare condition that can cause permanent liver damage. Eight deaths were reported among those cases.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
