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On July 2, 2020, Medwatcher Japan submitted an "Opinion on Avigan Based on Deaths Mentioned in 'the Interim Report of The Favipiravir Observational Study' by Fujita Health University (Regarding Covid-19)" to the Minister of Health, Labor and Welfare.

This is the second opinion following the opinion dated May 1.

The purpose of the request is as follows:

1_1 suspend the conditional supply of Avigan (generic name: favipiravir) to those participating in an observational study by Fujita Health University and the "COVID-19 REGISTRY JAPAN (joint study)" by NCGM, and the enrollment of new patients receiving the drug in both studies.

1_2 closely examine patients who were treated with Avigan and died within the first month of hospitalization after hospitalization (223 patients, 11.6%), as mentioned in an interim report by Fujita Health University's Favipiravir Observational Study Group, and the association between Avigan administration and death. We request that the results of both examinations are published.

1_3 make public the clinical course of death among those above who had minor illnesses (42 patients, 5.1%), without waiting for the results of the examinations described in the previous section.

2 MHLW should not approve Avigan for the treatment of COVID-19 without proof of efficacy through rigorous randomized controlled clinical trials and an appropriate assessment of the balance between risks and benefits.

Our opinion points out that according to the interim report, the mortality rate of patients treated with Avigan within approximately the first month of hospitalization was as high as 11.6%. This is clearly higher than the nationwide mortality rate of 1.6% that MHLW reported in its 2.1 edition of the Clinical Practice Guidance for COVID-19, which raised concerns about the risks of Avigan. Our opinion also points out that there was a serious ethical issue, such as the possibility of violating the Clinical Trials Act or the Clinical Research Guidelines, because Fujita Health University does not have a system in place to provide adequate explanations to protect study participants and manage adverse events.

In addition, since the government has indicated that it may approve Avigan without submitting data related to clinical studies under certain conditions, we reiterated our opposition to this and requested that Avigan should not be approved for the treatment of COVID-19 without proof of efficacy through rigorous randomized controlled clinical trials and an appropriate assessment of the balance between risks and benefits.


The full text is in the attached document below.

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