Amgen Seeks FDA Hearing To Challenge Proposed Tavneos Withdrawal

Amgen has formally requested an FDA hearing to challenge the proposed withdrawal of Tavneos (avacopan), a drug for treating ANCA-associated vasculitis. The company argues that the drug's benefits continue to outweigh its risks and plans to submit detailed data by June 29, 2026. An independent review of the pivotal clinical trial data by Duke Clinical Research Institute is currently underway.