The Ministry of Health, Labour and Welfare issued a notice concerning Kissei Pharmaceutical’s vasculitis treatment TabNeos, requesting that new administrations in Japan be withheld and treatment for patients currently receiving the drug be discontinued. The efficacy data are reportedly in question, and the situation is expected to lead to consideration of further measures, including administrative action.
The Ministry of Health, Labour and Welfare issued a notice asking medical institutions in Japan to withhold new administrations of Kissei Pharmaceutical’s TabNeos and to consider discontinuing treatment or switching to another treatment for patients already receiving the drug.
Following the public disclosure in May of a patient death caused by liver dysfunction, the drug was the subject of a Blue Letter safety alert. There have also been allegations of improper procedures in the international joint clinical trial. Withdrawal of approval has been recommended in the US, and reported in Europe.
At a subcommittee meeting dated the 23rd, the MHLW explained that it had determined that the data supporting efficacy were questionable. It indicated a policy of considering administrative action, including withdrawal of approval, by the end of the year, and attention is focused on developments going forward.