Overview
- Kissei Pharmaceutical, which sells Tavneos in Japan, told doctors on Friday to stop starting new patients and to reassess people already on the drug after 20 deaths were reported among users.
- The company also logged 22 cases of vanishing bile duct syndrome in Japan, a severe liver disorder that destroys the ducts that carry bile, with 13 of those patients dying.
- In the United States, the FDA moved on April 27 to withdraw approval, citing weak evidence of effectiveness and false statements in the original application.
- Amgen says it still stands by the medicine and continues to sell it, and it reports no known U.S. deaths tied to serious liver injury in more than 8,000 treated patients.
- European regulators are reviewing Tavneos, which is used for rare blood vessel inflammation called ANCA-associated vasculitis and has treated about 8,500 people in Japan since June 2022.