The number of patients who died from liver dysfunction in connection with the vasculitis treatment TabNeos reached 20, and the MHLW decided on a policy of withholding use in new patients. It is reported that administrative action, including withdrawal of approval, will be considered by the end of the year.
In Japan, 20 deaths from liver dysfunction were reported after patients took TabNeos (avacopan), a treatment for vasculitis. On the 21st, the Ministry of Health, Labour and Welfare decided to ask that use in new patients be withheld, stating that it had determined that information supporting efficacy was insufficient because questions had arisen concerning the clinical trial underpinning the approval.
In Europe, withdrawal of approval proceeded in August, while in the US there has been movement toward recommending withdrawal of approval. Japan is also expected to consider similar administrative action by the end of the year. Kissei Pharmaceutical handles sales in Japan, and awareness of risks similar to those identified overseas is spreading.