A pharmaceutical company has announced that it has begun a new clinical trial for Avigan, which has been postponed for approval as a treatment for the new coronavirus and is under ongoing deliberation.
As soon as the data is collected, it will be submitted to the Ministry of Health, Labor and Welfare for approval.
"Abigan" is a new influenza drug developed by Fujifilm Toyama Chemical, and an application for approval was submitted as a therapeutic drug for the new coronavirus, but it was "submitted" by the Council of the Ministry of Health, Labor and Welfare last December. Approval was postponed, saying, "The validity cannot be clearly judged from the data," and the deliberation was continued.
In response to this, FUJIFILM Tomiyama Chemical Co., Ltd. announced that it has started clinical trials in Japan under a new framework on the 20th.
The subjects are patients aged 50 years or older who have an underlying disease at high risk of aggravation, and start administration within 72 hours of the onset to see how much the aggravation can be suppressed.
The effect will be examined by comparing patients who received the real drug with those who received the fake drug, but in this new trial, not only the patients but also the doctors will collect data without knowing which is the real drug. That is.
A council of the Ministry of Health, Labor and Welfare pointed out that the doctor's prejudice may have influenced the data collected in the previous clinical trial while the doctor knew which one was the real one.
The clinical trial is scheduled to be conducted over October and data on more than 300 patients will be collected, and as soon as it is completed, it will be submitted to the Ministry of Health, Labor and Welfare for approval.
FUJIFILM Toyama Kagaku commented, "We would like to establish a treatment method to prevent the aggravation so that we can avoid the tightness of the bed."