20 Patients Die after Receiving Vasculitis Drug Tavneos

Tokyo, May 18 (Jiji Press)–Kissei Pharmaceutical Co. has announced that 20 patients were reported to have died after receiving Tavneos, a vasculitis drug sold by the firm in Japan. According to the company and other sources, Tavneos, developed by ChemoCentryx Inc., a subsidiary of U.S. drugmaker Amgen Inc., is estimated have been administered to about 8,500 patients by the end of April, since its release in Japan in June 2022. Liver dysfunction, which the drug’s package insert cites as a possible side effect, was observed in the 20 patients. Kissei Pharmaceutical is investigating a possible causal relationship between the drug and the deaths. In light of the death reports, Japan’s health ministry has instructed the company, based in the central city of Matsumoto, Nagano Prefecture, to warn against administering the drug to new patients. It plans to demand that the package insert include a warning about the risk of liver dysfunction. The ministry also plans to revoke the drug’s approval or conduct an on-site inspection of the company, if necessary. In April, the U.S. Food and Drug Administration proposed canceling the drug’s approval in the United States, after a false statement was found in the application document and doubts were raised about the drug’s efficacy. END [Copyright The Jiji Press, Ltd.]