"Confirmation of certain efficacy of Avigan clinical trial" Application for approval by the end of next month September 23, 15:04
The company that developed the drug, Avigan, has announced that it has been shown to be effective in clinical trials in patients infected with the new coronavirus.
We are planning to apply for approval as a therapeutic drug for the new coronavirus by the end of next month.
"Abigan" is an antiviral drug developed by Fujifilm Toyama Chemical Co., Ltd., and has been administered to patients with the new coronavirus, which has relatively mild symptoms, within the framework of research to observe the condition.
According to FUJIFILM, in a clinical trial to administer to patients and aim for national approval, 156 patients aged 20 to 74 years were examined for the period until their symptoms improved and the PCR test became negative. In the group that did not receive Avigan, it was 14.7 days, while in the group that received Avigan, it was 11.9 days, which was about 3 days shorter.
In addition, there were no side effects other than the previously known declines in renal and liver function, and there were no new concerns regarding safety.
In response, the company plans to apply for approval as a treatment for the new coronavirus by the end of next month.
The clinical trial of "Abigan" was originally scheduled until the end of June, but the schedule was extended due to reasons such as the number of infected people decreased, and during this period, groups such as Fujita Medical University were patients. In a clinical study of 88 patients, the results were announced that no statistically clear efficacy could be confirmed.
As a therapeutic drug for the new coronavirus, "remdesivir", which has been developed as a therapeutic drug for Ebola hemorrhagic fever, has been approved, and the steroid drug "dexamethasone" is recommended.