Major Medical Journal Retracts Pivotal Trial for Amgen's Vasculitis Drug

The New England Journal of Medicine has retracted a key study that underpinned the FDA's approval of avacopan (Tavneos) for ANCA-associated vasculitis. This decision follows an FDA investigation uncovering undisclosed data irregularities, specifically the re-adjudication of primary endpoint assessments after the trial was unblinded. The European Medicines Agency had previously advised against the drug's marketing authorization due to these issues and reported cases of severe liver injury, including fatalities.