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Fujifilm is moving quickly into phase III clinical trials of Avigan Tablets for COVID-19 and they are committed to increasing production. We have been covering this “wonder drug” for a while now  ( 1, 2, 3, 4, 5, 6) and every day there seems to be more positive news about Avigan now. For those unaware here are the IV levels of trial and what the cover:

1. Phase 0 clinical trials: Exploring if and how a new drug may work
2. Phase I clinical trials: Is the treatment safe?
3. Phase II clinical trials: Does the treatment work?
4. Phase III clinical trials: Is it better than what’s already available?
5. Submission for FDA approval: New drug application (NDA)
6. Phase IV clinical trials: What else do we need to know?

Once Fujifilm passes Phase III they can submit Avigan Tablets to the FDA for use in the United States for the treatment of COVID-19, which is probably similar in other countries. You can read the full press release below

Press Release:
Fujifilm announces the start of a phase III clinical trial of influenza antiviral drug “Avigan Tablet” on COVID-19 and commits to increasing production
TOKYO, March 31, 2020 — FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada) has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug “Avigan Tablet” (generic name: favipiravir) in Japan for patients of COVID-19, a respiratory infection caused by the novel Coronavirus (SARS-CoV-2).

Following the rapid and global outbreak of COVID-19, on March 11 2020 the World Health Organization (WHO) announced the Coronavirus had become a global pandemic. As the number of COVID-19 patients continues to increase around the world, the development of effective treatments is urgently required. Read More »

Western media is starting to catch up with Fujifilm Avigan coverage while Asian media has been almost exclusively covering the wonder drug. Fiercepharma published some more information about Avigan (favipiravir) based on a report by Nikkei Asian Review that gives some insight into how the drug works for those interested. Fujifilm also released a statement Friday which we covered here.

Fujifilm pointed out in its announcement that favipiravir, the active pharmaceutical ingredient in the tablet, has a “mechanism of action that prevents the propagation of viruses…that might  have an antiviral effect on the novel coronavirus.” COVID-19 is classified into the same type (single-stranded RNA virus) as influenza virus. To test that possibility, clinical trials are underway to seek “clear evidence of the drug’s efficacy and safety,” Fujifilm said.

Avigan has been rolled out before, including in 2015 against Ebola and in 2016 for avian influenza. At the time, the company made this prophetic observation:

“The need to develop new drugs for treating influenza has come amidst mounting concerns–in recent years that avian influenza viruses could mutate into a new type of virus, capable of human-to-human transmission. Such a mutation could potentially trigger a pandemic.”

The Japanese Prime Minister Shinzo Abe also made a statement over the weekend based on reports that clinical trials of the drug in China showed it effective against COVID-19. Japan will begin trials of the drug on COVID-19 in cooperation with other countries and ramp up production with the aim of a quick approval, as reported by Nikkei Asia Review. It was also announced that Fujifilm is ready to mass-produce the drug for countries interested. This is our 6th report about Avigan (favipiravir) ( 1, 2, 3, 4, 5) and so far the drug has had overwhelmingly positive results.

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via Fiercepharma, Nikkei Asian Review, Nikkei Asian Review 2