Japan Questions Reliability of Vasculitis Drug Approval Data

Tokyo, Oct. 21 (Jiji Press)--Japan's health ministry said Wednesday that there may be problems with the reliability of documents submitted by Kissei Pharmaceutical Co. for the approval of vasculitis drug Tavneos.

In its response to a series of deaths among Tavneos users, the ministry reiterated its request that medical institutions refrain from starting new patients on the drug, which is marketed by Kissei Pharmaceutical, based in Matsumoto, Nagano Prefecture, central Japan.

The ministry plans to decide by the end of this year on administrative action, potentially including revocation of the drug's approval.

Tavneos was launched in Japan in June 2022 after receiving approval from the ministry. Its package insert listed liver dysfunction as a serious side effect.

Kissei Pharmaceutical reported in May this year that 20 Tavneos users had died of liver dysfunction. It was later found, however, that one of the reported deaths was due to another factor.

[Copyright The Jiji Press, Ltd.]