Amgen says no known US deaths tied to TAVNEOS liver injury reports in Japan

Amgen Inc.

Amgen Inc.

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  • Amgen issued a clarification on May 15, 2026 following media reports in Japan of 20 deaths tied to patients treated with TAVNEOS (avacopan).
  • The company said the Japanese report referenced a regulatory notification that lacked context, citing 20 fatal cases of serious liver injury reported by Kissei out of more than 8,500 patients treated in Japan, including cases where causality could not be determined.
  • It said there have been no known US deaths linked to serious liver injury, including vanishing bile duct syndrome, among more than 8,000 US patients treated with TAVNEOS.
  • Amgen said US labeling since 2021 has warned of hepatotoxicity risk with specific liver monitoring guidance, adding it continues to review global safety data and engage with the FDA.
  • It maintained TAVNEOS has a favorable benefit-risk profile for ANCA-associated vasculitis.


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