Amgen Statement on TAVNEOS® (avacopan)
On May 15, 2026, media outlets reported 20 deaths associated with patients being treated with TAVNEOS® (avacopan) in Japan. The report was based on a regulatory notification in Japan and lacked important context. Amgen believes it is important to provide that context for the benefit of clinicians and patients.
Kissei, which owns the rights to TAVNEOS in Japan, reported 20 fatal cases of serious liver injury, from over 8,500 patients who have been treated with TAVNEOS in Japan. These figures include cases for which a causal relationship with the product could not be determined.
There have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS.
TAVNEOS is an important and effective medicine that treats anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. ANCA-associated vasculitis (AAV) is a rare and serious disease in which the immune system attacks blood vessels and can damage major organs. Severe AAV can be life-threatening, with five-year mortality rates over 20%. Without treatment, mortality rates may exceed 90% after the first year. Even with treatment, many patients face ongoing health problems and major impacts on daily life.
Since the U.S. approval in 2021, the U.S. prescribing information has included reference to the risk of serious liver injury (hepatotoxicity) and has provided specific liver monitoring guidance for physicians and patients. Amgen continuously reviews global safety data and shares updated information with the FDA.
Amgen acquired Chemocentryx in 2022, a year after the product launched in the U.S. and currently holds U.S. rights for TAVNEOS. Vifor Fresenius Medical Care Renal Pharma (now CSL-Vifor) acquired ex-US commercial rights to TAVNEOS in 2016 from Chemocentryx. Kissei obtained exclusive rights for TAVNEOS in Japan from Vifor in 2017.
Interactions with regulatory agencies, clinicians and patients outside the U.S are handled by the companies that have ownership rights for the medicine in those jurisdictions.
Based on all available data, Amgen continues to believe TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile for patients living with AAV. Amgen continues to engage with the FDA regarding TAVNEOS. Our focus remains on patient safety, patient needs, and ongoing support for the AAV community.