Avigan "Premature clinical research continued for efficacy judgment" New Corona May 19 22:55
With regard to "Abigan", which is expected to be a candidate for a new coronavirus therapeutic agent, the efficacy has not been determined so far by clinical studies conducted in Japan, and further clinical studies need to be conducted for verification. I knew it was.
Avigan is a new influenza drug developed by a Japanese pharmaceutical company, and the Chinese government announced in March that a clinical study confirmed that it was effective against the new coronavirus, confirming its efficacy and safety in Japan. Clinical studies and clinical trials are being conducted.
Among these, clinical studies in Japan were conducted on 86 patients with mild or asymptomatic who are admitted to multiple facilities such as Fujita Medical University in Aichi Prefecture, who are given abigan for up to 10 days from the first day of admission. And it is done by dividing into those who are administered on the 6th day after hospitalization and comparing whether the virus is decreasing at the 6th day.
The clinical study is to be evaluated by a third-party committee, and according to the people involved, an interim analysis of more than half of the 40 patients showed that "it is too early to judge efficacy. Therefore, the opinion that "the clinical research should be continued" was made.
Opinions are sought to discontinue the study if there are any apparent efficacy or safety concerns at intermediate stages, but at this stage further studies should be continued to assess efficacy. I have reached the conclusion.
The Ministry of Health, Labor and Welfare says that it plans to approve Avigan as a therapeutic drug by the end of this month by significantly shortening the procedure.