The UK’s MHRA joined the EMA in withdrawing Amgen’s Tavneos (avacopan) from the market and banning new patient use as of Sept. 1, with limited continued supply for existing patients. MHRA said supplies will be available for the next six months to help vasculitis patients transition to alternative therapies. The coordinated withdrawal illustrates how regulatory actions can converge across regions, especially for complex immune and oncology-adjacent modalities where benefit-risk assessments can change. The decision also raises operational questions for healthcare providers managing C5a complement inhibitor regimens. For Amgen, the withdrawal impacts commercial access immediately for new starts in the UK while creating a transition period for current patients.
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