Back to the Drawing Board for Fujifilm Holdings’ Favipiravir in Japan as it Must Now Execute Another Phase 3 Clinical Trial

Back to the Drawing Board for Fujifilm Holdings’ Favipiravir in Japan as it Must Now Execute Another Phase 3 Cliicial Trial

Japanese drug regulatory authorities failed to make a decision on whether favipiravir (Avigan) would be used as a treatment for COVID-19 alongside remdesivir (Gilead’s Veklury) and dexamethasone, the latter in severe cases. Approved in numerous countries, from Russia and Indonesia and India on an emergency basis, Japan’s health ministry simply delayed any decision. While the drug’s targeted indication was patients with early onset, mild COVID-19, the Japanese regulators are on record that it was too difficult for them to identify the drug’s efficacy from existing data. This has led to a complete regrouping for the drug’s makerFujifilm Holdings—and its approach. Fujifilm will embark on a new clinical trials program in close collaboration upfront with the Ministry of Health, Labor and Welfare in a bid to improve scope and methods in a bid to bolster chances of better results.

For now, when someone is hospitalized in Japan with COVID-19, they will either receive Gilead’s remdesivir or under select, more severe conditions, dexamethasone. The new placebo-controlled clinical trial, reports Nikkei, will include patients who are 65+ of age with mild COVID-19 symptoms in addition to those 50 and up and mildly ill who may have existing health conditions, such as diabetes or kidney disorders. This time, a double-blinded study involving up to 270 participants, the bar is high for regulators in places such as Japan, the USA or Europe. With an end date targeting the Fall, Fujifilm hopes to seek approval by October 2021.

Favipiravir Approval and Authorization

As chronicled frequently in TrialSite, Favipiravir has been approved in generic form in numerous countries from India and China to Russia as an antiviral for mild onset COVID-19 cases. However, except for a few possible exceptions in Eastern Europe, no nations in the EU nor the United States have approved the drug. Indian generic pharmaceutical company Dr. Reddy’s has submitted for authorization a generic version of favipiravir in Canada toward the end of last year. So far, two months later, no word from Health Canada.

The antiviral drug is meant to be the first drug in Japan to treat those mildly ill. However, it cannot be used by pregnant women as it has been found to possibly have adverse impacts on the fetus.

Risks to the Next Trial

But some of the same challenges facing the last clinical trial in 2020 could happen now in 2021. With a decrease in infected patients to severe stress on existing health organization staff, a lack of participation can spell the end of any clinical trial: in fact, a majority of clinical trials in the developed world are delayed most often due to participation challenges. This could happen again leading to the end of Avigan as a possible therapy for COVID-19 patients in Japan.

From an economic vantage, this benefits Gilead as Remdesivir will continue to be the go-to product in Japan for treating COVID-19 for anyone hospitalized with the condition for the foreseeable future.