Healio6/10/2026Somewhat-Bearish (-0.207)
FDA seeks to withdraw avacopan approval over alleged data manipulation, false statements
The FDA is seeking to withdraw its approval of avacopan (Tavneos) for ANCA-associated vasculitis, alleging data manipulation and false statements were made by the original manufacturer, ChemoCentryx, during the drug's trial. Amgen, which acquired avacopan, disputes these claims and maintains the drug's safety and efficacy, while also addressing post-marketing concerns about liver injury and vanishing bile duct syndrome. The situation has led to a high-stakes disagreement with Amgen refusing to voluntarily withdraw the drug and the FDA calling for a hearing.
