The Ministry of Health, Labour and Welfare requested that medical institutions halt new administrations after 23 people were reportedly killed by liver dysfunction following treatment with the vasculitis drug Tavneos. The ministry indicated that the reliability of the materials submitted with the application for approval may be problematic and plans to decide on measures, including administrative action, by the end of the year.
The Ministry of Health, Labour and Welfare has disclosed its policy response to a series of patient deaths following treatment with Tavneos, a vasculitis drug marketed in Japan. The reliability of the materials submitted with the application for approval may be problematic, and the ministry has requested that medical institutions halt new administrations.
The drug began being marketed in Japan in June 2022. It has newly been confirmed that the number of people who have died from liver dysfunction has reached 23, and the view is that causality could not be ruled out in 6 of those cases. In response, US and European regulators have pointed to inappropriate aspects of the clinical trials and development methods.
The Ministry of Health, Labour and Welfare has suggested that it may decide on administrative action by the end of the year, and is reportedly considering measures that could include revocation of the drug's approval. It has been explained that the trial results cited as the basis for approval were based on data provided by a US pharmaceutical company.
Approval revocation is progressing in Europe, and it is reported that revocation is also likely to be recommended in the United States. The Ministry of Health, Labour and Welfare's formal decision on administrative action and the market response to the drug will be closely watched in follow-up reports.