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U.S. Registry Data Confirm Liver Risk With Avacopan for Vasculitis Treatment

August 24, 2026

Source Summary

A new study using U.S. registry data has confirmed liver risk associated with avacopan (Tavneos), a drug approved in 2021 by the FDA to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The FDA has requested that manufacturer Amgen withdraw the drug from the market.

Why it matters

The confirmed liver risk strengthens the FDA's position to remove a drug from the market that was approved for a serious autoimmune condition, affecting treatment options for patients with ANCA-associated vasculitis.

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