Japanese pharmaceutical company Kissei Pharmaceutical has reported 20 deaths in patients taking Tavneos to treat vasculitis.
The company stressed that a causal link to the drug has not been established in all cases. Due to the identified cases of severe liver injury, the company urged healthcare facilities to refrain from prescribing the drug to new patients. The company also stressed that it is consulting with the Japanese Ministry of Health on the current situation.
According to Kissei Pharmaceutical, approximately 8,500 patients in Japan have received the drug since its launch in 2022. Patients already receiving treatment are advised to be informed about the risks of liver damage and consider alternative treatment options, although liver damage was initially listed as a serious side effect.
The drug was developed by the American company ChemoCentryx, a subsidiary of Amgen. On April 27, the US Food and Drug Administration (FDA) announced its intention to revoke the drug's registration in the US due to inaccurate information in the registration dossier and concerns about its effectiveness.