Approved as an anti-flu drug in 2014 in Japan, Avigan (favipiravir) was repurposed by Japan’s Fujifilm Holdings Corp (Fujifilm) to treat COVID-19 patients in 2020. The drug is considered a promising COVID-19 medicine and was strongly promoted by the former Japanese Prime Minister Shinzo Abe.
A Tough Road to Approval
However, Avigan’s path towards approval is proving to be a tough one. In December 2020, Japan postponed the request to authorize Avigan for mild to moderate COVID-19 patients due to inconclusive trial data with which it was hard to judge efficacy.
Moreover, nine clinical trials conducted globally showed that Avigan could treat mild to moderate patients in early hospitalization but didn’t decrease patient mortality with statistical significance.
Restarting Clinical Trials
Following the consultation with Japan’s Ministry of Health, Labor and Welfare, Fujifilm may restart the clinical trials with 270 patients, including COVID-19 patients with mild symptoms who are above 65 years old and those who are over 50 years old and under existing health conditions. The trials might start in April at the earliest and last until October, following which the company expects to seek regulatory approval.
Current COVID-19 Treatments in Japan
Avigan has been granted an emergency use authorization for COVID-19 patients in China, Russia, India, and Indonesia. In Japan, however, there are only 2 approved COVID-19 treatments, dexamethasone, and remdesivir.
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