Home / Health / FDA Proposes Tavneos Ban Amid Data Manipulation Claims
FDA Proposes Tavneos Ban Amid Data Manipulation Claims
6 Jun
Summary
- Journal investigating research misconduct in a key study for Amgen's drug Tavneos.
- FDA proposed pulling the drug, citing manipulated data used in its approval.
- Study results allegedly showed drug superiority only after patient data was altered.
The New England Journal of Medicine is actively investigating claims of research misconduct surrounding a critical study that supported the approval of Amgen Inc.'s drug, Tavneos. This investigation follows a recent proposal by the US Food and Drug Administration to remove the medication from the market, based on allegations that the approval process involved manipulated data.
A spokesperson for the journal, which published the study in 2021, stated that they take such allegations very seriously and anticipate a resolution soon. Amgen, which acquired Tavneos through its purchase of ChemoCentryx in 2022, continues to market the drug for treating ANCA-associated vasculitis, a rare blood vessel inflammation, asserting that its benefits surpass its risks.
The FDA's concerns highlight that the core conclusion of the NEJM study—that Tavneos is superior to standard care after one year—may be compromised. Prior to the alleged alteration of several patients' results, the trial reportedly failed to demonstrate this superiority, according to the FDA's letter proposing the drug's withdrawal. Amgen has indicated it requested a hearing regarding the FDA's proposal and has until June 29 to present its supporting data.
