The clinical trial used in the approval process for Amgen’s drug Tavneos has been withdrawn from the New England Journal of Medicine. The journal announced that the article, published in 2021, was withdrawn at the request of two of its academic authors.
The study in question evaluated the use of avacopan in the treatment of ANCA-associated vasculitis. Avacopan, marketed under the brand name Tavneos, is known as one of the key drugs in Amgen’s portfolio.
According to the retraction notice published by the NEJM, as part of an ongoing U.S. Food and Drug Administration investigation conducted after publication, it was determined that the primary endpoint assessments for nine patients in the study were re-evaluated after the database had been locked and the study’s blinding had been lifted.
The journal stated that this re-evaluation was not disclosed in the article and was inconsistent with proper research conduct principles. NEJM editors announced that the article was therefore retracted.
The retraction notice also revealed that these actions took place without the knowledge of the article’s two academic authors. While it was noted that the FDA investigation is ongoing, this development has reignited scrutiny of the clinical data used as the basis for Tavneos’s approval process.
