Move follows actions 'inconsistent with proper research conduct,' journal says
— Move follows actions "inconsistent with proper research conduct," journal says
by Ian Ingram, Managing Editor, MedPage Today
June 30, 2026
• 2 min read
The New England Journal of Medicine (NEJM) retracted the pivotal study supporting FDA's approval of avacopan (Tavneos) for severe forms of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
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NEJM retracts pivotal data behind Amgen's Tavneos after FDA probe finds results for 9 patients re-evaluated post-unblinding; EU…
Trial data 'can no longer be relied upon' to demonstrate drug's efficacy, EMA committee says
The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the original…
An Amgen spokesperson said it "takes scientific integrity seriously and respects the role of journals in upholding the peer…
Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth…
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…
