日本厚生劳动省周三表示，吉赛伊制药提交的血管炎药物Tavneos的审批文件可能存在可靠性问题。
Japan’s health ministry said Wednesday that there may be problems with the reliability of documents submitted by Kissei Pharmaceutical for the approval of vasculitis drug Tavneos.
在回应Tavneos使用者一系列死亡事件时，厚生劳动省再次要求医疗机构暂不为新患者开始使用该药物，该药由位于长野县松本市的吉赛伊制药销售。
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.
厚生劳动省计划在今年年底前决定行政处分，可能包括撤销该药的批准。
The ministry plans to decide by the end of this year on administrative action, potentially including revocation of the drug’s approval.
Tavneos于2022年6月在日本上市，此前已获得厚生劳动省批准。其说明书将肝功能障碍列为严重副作用。
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.
吉赛伊制药今年5月报告称，20名Tavneos使用者死于肝功能障碍。不过，后来发现，其中一起报告的死亡是由其他因素造成的。
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.
据厚生劳动省称，此后又确认了四起致死病例，使死于肝功能障碍的总人数达到23人。其中六起病例无法排除与该药物的因果关系。
According to the ministry, four additional fatal cases have since been confirmed, taking the total number of deaths from liver dysfunction to 23. In six of the cases, a causal relationship with the drug could not be ruled out.
厚生劳动省根据开发该药的美国制药公司进行的临床试验结果批准了Tavneos。然而，美国和欧洲的监管机构对该试验方法的适当性提出了担忧。
The ministry approved Tavneos based on the results of a clinical trial conducted by the U.S. pharmaceutical company that developed the drug. Regulatory authorities in the United States and Europe have raised concerns about the appropriateness of the trial methodology, however.
欧洲监管机构于8月撤销了该药的批准，而美国监管机构建议撤销批准。
European authorities revoked the drug’s approval in August, while U.S. authorities recommended that the approval be withdrawn.
6月，厚生劳动省责令吉赛伊制药提交关于该药的报告。医药品医疗器械综合机构分析了该公司的回应，并编制了一份报告。
In June, the ministry ordered Kissei Pharmaceutical to submit a report on the drug. The Pharmaceuticals and Medical Devices Agency analyzed the company’s response and compiled a report.
在报告中，该机构表示临床试验结果可能存在可靠性问题，且将其作为药物疗效证据是不恰当的。关于安全性，它指出自五月以来采取的措施已产生一定效果，但仍需密切关注肝功能异常。该机构还表示，无法得出药物的益处大于风险的结论。
In the report, the agency said that the clinical trial results may have reliability issues and that it was inappropriate to use them as evidence of the drug’s efficacy. Regarding safety, it said that measures taken since May have had some effect, while noting that liver dysfunction still requires close attention. The agency also said that it could not conclude that the drug’s benefits outweigh its risks.
报告发布后，卫生部呼吁医疗机构不要为新患者启动该药物。然而，鉴于该药用于治疗严重指定的顽固性疾病，卫生部要求医疗机构将停用该药或转用替代疗法作为已在使用患者的一般做法。
Following the report, the ministry called on medical institutions to refrain from starting new patients on the drug. However, given that it is used to treat serious designated intractable diseases, the ministry asked medical institutions to make discontinuation of the drug or a switch to alternative therapies the general rule for patients already receiving it.