Japanese Health Ministry Could Approve Favipiravir (Avigan) Before End of Year Targeting COVID-19

Japanese Health Ministry Could Approve Favipiravir (Avigan) Before End of Year Targeting COVID-19

Although favipiravir (Avigan) was developed and approved for Japan for influenza in 2014, the drug isn’t yet approved for COVID-19 but that may change soon. After all, favipiravir has been approved by some of the most populated nations on the planet, from India and Russia to China and Bangladesh. The U.S. Department of Defense (DoD) spent over $200 million to support favipiravir-based clinical trials just five years ago as well. Reports out of Japan reveal that the nation’s health ministry may give the approval this year.

A Brief Review

TrialSite has been one of the few media platforms chronicling the use of favipiravir around the world. Given that the antiviral drug not only has been approved in Russia, India, China, Bangladesh and others but also that the U.S. government evidenced keen interest funding major clinical trials, only perplexes us as to why there is so little coverage. Why isn’t there interest?  

Earlier in September, TrialSite wondered can Favipiravir compete against Remdesivir? After all, the DoD must have seen something in this drug given it put up a total of at least $211.3 million just five years ago.

Cleary, Russia sees some promise as they approved a generic version called Avifavir, while India has now several generic versions in pharmacies. TrialSite continued to ask the question, however: what is the real efficacy data? Apparently, there is enough data from research to convince regulators to move forward but in the age of COVID-19, where speed is the name of the game in drug development, the questioning must continue. TrialSite provides some summary data in articles such as here

On to Japan

Now Japan is a traditional and conservative culture. It’s most certainly not a place where rushed drug development is commonly accepted. The Nikkei Asian Review recently suggested that the Japanese government may be ready to consider acceptance of this indigenous drug. The media learned that the health ministry in fact could approve the drug before the end of the year, making it the third such approved drug for COVID-19, including dexamethasone and remdesivir.

Already in Use Off Label

Nikkei Asian Review informs that in fact Avigan (trade name for favipiravir) is already in use by certain hospitals and health systems. So currently, authorities allow off label use for patients with COVID-19 in observational or perhaps case series studies. However, approval would open up far wider usage.

Japanese Health Ministry Acknowledges Potential Fast-Track

The drug was initially developed as a flu treatment by developer Fujifilm Toyama Chemical. The sponsor initiated clinical trials back in March, which concluded recently. Nikkei Asian Review reports that the study results are still under review, but the prominent news platform reports that “…[T]he drug apparently has shown some effectiveness against coronavirus.”

Apparently, the Japanese health ministry will fast-track approval should the data review turn out positive. Recently, a ministry source quoted, “If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application.” The government, via the previous Prime Minister Shinzo Abe, sought a fast-track previously but there was a lack of patient subjects.

North American Activity

Sponsors of one kind or another are conducting at least 34 favipiravir-based clinical trials targeting COVID-19. In Canada, Appili Therapeutics is working on developing and commercializing the product for the North American market. Meanwhile, prestigious universities, such as Stanford, conduct favipiravir studies in the United States. Fujifilm Toyama Chemical itself is conducting a U.S.-based clinical trial (NCT04358549) scheduled for completion November 1, 2020.


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