Regarding the end of enrollment of subjects in the Japanese clinical phase III study for patients with the new coronavirus infection, the anti-influenza virus drug “Avigan ® Tablets”
FUJIFILM Toyama Chemical Co., Ltd. (Headquarters: Chuo-ku, Tokyo / President: Junji Okada, hereafter FUJIFILM Toyama Chemical) has announced the anti-influenza virus drug “Avigan ® Tablets” (generic name: favipiravir) (hereinafter “Avigan”). We are pleased to announce that the enrollment of subjects in the domestic phase III clinical study for patients with new coronavirus infection (hereinafter referred to as COVID-19), which is currently being conducted, will be completed at the end of March this year.
The ongoing domestic phase III clinical trial was started in April 2021 with the aim of confirming the aggravation-suppressing effect of “Avigan” on COVID-19 patients. With the epidemic of Omicron strains, which have a lower severity rate than conventional strains, and it is estimated that most of the patients recently enrolled in this study are infected with Omicron strains, we will continue the trial with the current clinical trial protocol. However, since it will be difficult to verify the aggravation-suppressing effect of “Avigan” and the continuation of the study using placebo will not be in the interests of the subjects, we have terminated the inclusion of new subjects in this study. I decided to do it. In the future, we will proceed with analysis of the included patient clinical trial data according to the clinical trial protocol.
To date, no serious adverse events for which a causal relationship with the investigational drug cannot be ruled out have been confirmed in this study.
Overview of ongoing domestic phase III clinical trials
Start time April 2021
Target patients Early-onset COVID-19 patients with aggravation risk factors
Test method Double-blind, placebo-controlled trial
Primary endpoint Percentage of severely ill patients
[Reference] About “Avigan ® Tablets”
It is an anti-influenza virus drug that was approved for manufacture and sale in Japan in March 2014 for the indication of new or re-emerging influenza virus. Consider administration to patients when new or re-emerging influenza virus infections in which other anti-influenza virus drugs are ineffective or ineffective occur and the government determines that this drug should be used as a countermeasure against the influenza virus. It is a drug that is used.
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