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On May 1, 2020, Medwatcher Japan submitted an "Opinion on Avigan (regarding COVID-19)" to the Minister of Health, Labor and Welfare.

Avigan (generic name: favipiravir) is an anti-influenza drug approved in March 2014. Even though it is an approved drug, it is not a drug that has been approved with efficacy and safety confirmed.

While it was found to have strong teratogenicity, not only did it fail to show non-inferiority compared to Tamiflu, but it also failed to demonstrate robust efficacy compared to a placebo. Under normal circumstances, approval would not have been possible, but the drug was approved under the unusual conditions that it should not be distributed but will be stockpiled in case.

Now, Avigan is being hyped as a potential treatment for COVID-19 without scientific evidence, and we are very concerned about this situation.

Therefore, we have submitted the above opinion requesting that the following be done with caution: the use of Avigan for the treatment of COVID-19 outside clinical trials (off-label use conducted as "observational studies") and the handling of applications for approval when submitted.

The full text is in the attached document below.

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