Pivotal data for Amgen’s Tavneos have been retracted from the New England Journal of Medicine, creating another obstacle for the beleaguered autoimmune drug, reports Endpoints.
Two academic authors requested the retraction citing an ongoing FDA investigation that suggested results for nine patients were re-evaluated after the trial was unblinded. NEJM editor-in-chief Eric Rubin said on Monday that this “was not disclosed in the article and is inconsistent with proper research conduct”.
Amgen has been going back and forth with the FDA since January, when the agency asked it to voluntarily take Tavneos off the market. The FDA cited concerns about Tavneos’ data and cases of drug-induced liver injury. When Amgen refused to pull Tavneos from the market, the agency ramped up the fight.
In April, the Centre for Drug Evaluation and Research (CDER) published a proposal to withdraw the drug, accusing study personnel of manipulating trial results used for the approval.
Amgen continues to defend Tavneos, which was approved in 2021 for a rare autoimmune disease called ANCA-associated vasculitis. The company asked for a hearing with the FDA earlier this month. On Monday, Amgen said it will submit data from an “independent, fully blinded re-adjudication of the primary endpoint results”, which was initiated in February 2026.
A spokesperson said the company “takes scientific integrity seriously and respects the role of journals in upholding the peer review process”.
Meanwhile, Amgen also has to answer to European regulators. Last week, the European Medicines Agency proposed revoking Tavneos’s marketing authorisation, citing “incorrect and misleading” clinical data. The agency’s human medicines committee (CHMP) said the original study was in “breach of good clinical practice” and concluded that the drug’s benefit no longer outweighs its risks.
Endpoints News article – NEJM retracts pivotal data for Amgen's Tavneos (Open access)
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