Amgen’s Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resume

Amgen's Tavneos (avacopan) is under heightened scrutiny for serious liver injury, including vanishing bile duct syndrome and fatal outcomes, with most cases reported in Japan.

Japan's regulatory environment has responded to the signal by updating the label and restricting new use, while the medicine remains approved and current patients may continue under close monitoring.

Kissei Pharmaceutical, which markets Tavneos in Japan, has recommended that doctors not start new patients on the drug and to reassess existing patients, following 20 reported deaths and several cases of severe liver dysfunction, though not all are confirmed to be caused by the medicine.

Amgen acknowledges the Japanese deaths and severe liver‑injury cases, emphasizes that hepatotoxicity and the risk of vanishing bile duct syndrome are now included in Tavneos labeling, and continues post‑marketing studies to better characterize the risk across multiple countries, including Japan.