Ukraine Ministry of Health to Formally Register Favipiravir as a COVID-19 Treatment

Ukraine Ministry of Health to Formally Register Favipiravir as a COVID-19 Treatment

TrialSite reported that in Russia, the Ministry of Health approved the generic form of Favipiravir, the Japanese generic of the antiviral drug Avigan. And most recently, the drug’s original developer, FUJIFILM Toyama Chemical Co, completed clinical trials evidencing sufficient safety and efficacy. That company just submitted a registration to the Ministry of Health, Labor, and Welfare in Japan. In Ukraine, Favipiravir has been on the national protocol as an emergency drug to treat COVID-19; however, it wasn’t registered; hence it wasn’t for sale in any commercial way. A Ukrainian pharmaceutical company just submitted to the Ministry of Health’s State Expert Center registration documents for the generic drug called Favipiravir-Microkhim. The odds are high that the regulatory body for this geographically large Eastern European nation will offer the greenlight.

COVID-19 In Ukraine

The Ukrainian population has experienced a steady rise in the incidence of COVID-19. The U.S. CDC considers that nation a Level 3 “high risk” location. With about 42 million people residing in the country, approximately 316,000 coronavirus cases have been recorded thus far, with just under 6,000 fatalities. OECD also shares figures and reports that its fatality rate is 2.1%. Problematically, the country faces shortages of medical supplies for acute care, from masks and protective suits to ventilators. To put matters in perspective, the country has approximately 83 ventilators per million inhabitants compared to 302 in Germany. Recently, a well-known Ukrainian fitness celebrity who downplayed the threat from COVID-19 died from the disease.

Ukraine Leverages COVID to Push for Universal Health Care Objective

During this crisis, the country’s political class may be on the verge of establishing universal health care coverage, according to a news story from the World Health Organization.

Interestingly, the COVID-19 pandemic has triggered a fundamental sea change in life for people all over the world—from economic structures to regulatory schemes to the impact on healthcare systems.   

Evidence of Favipiravir Success

There is mounting evidence that Favipiravir does help treat COVID-19 in a similar way to that of Remdesivir, in that it can reduce the duration of the illness. Russia has approved a form of the drug known as Avifavir while the drug is listed on the national protocol for India—several generic producers have developed generic products, and sales have been robust during the pandemic.  

Most recently, the drug’s maker, FUJIFILM Toyama Chemical Co., moved to register the drug with Japanese authorities in a bid to add the indication of COVID-19. It’s already approved for influenza, and it is a drug that is part of the national stockpile program.

As reported recently in UKRINFORM, its believed in that country that Favipiravir affects the pathogenesis of SARS-CoV-2 in humans. The safety profile appears well known and overall predictable. However, TrialSite has found some concerns or critiques, which can be read in the Sept. 3 article Can Favipiravir Compete Against Remdesivir in North America Targeting COVID-19?

Ukrainian Deal with Japanese

By early October 2020, the Ukrainian Cabinet of Ministers approved a draft agreement between the eastern European nation and Japan for a “transfer of the Favipiravir drug batch as the humanitarian aid for Ukraine” reports UKRINFORM, the national news agency of Ukraine. 

Who is Microkhim?

Microkhim is a generic pharmaceutical company founded in 1991. With about 500 employees, the company positions itself as a “full-cycle producer of pharmaceuticals, including R&D and full-scale production.

TrialSite Commentary

Favipiravir is also under investigation in the United States in a handful of clinical trials at prominent academic medical centers such as Stanford. Additionally, a Canadian biotech upstart, Appili Therapeutics, has initiated studies in a bid to commercialize the drug in North America.

As compared to Remdesivir, scant to no press time is given to this orally consumed drug. Currently, remdesivir can only be received via intravenous injection in the hospital. But a growing consensus directs the importance of proactive care upfront in ambulatory/community settings. Remdesivir is on target to generate between $1 billion and $3 billion in the first 12 months since its emergency use authorization.

Favipiravir can be taken in tablet form, and in the most recent Japanese study has been shown to inhibit the disease progression. Should the U.S. national research agencies consider some expenditure into more extensive testing this drug? As recently as 2015, over $200 million was spent by the U.S. government to investigate this same drug. Clearly, it must have shown some potential as a powerful antiviral candidate for such expenditure? 

Given the drug’s approval (whether permanently or provisional for the pandemic) in Russia, India, China, and several other nations now (and probably soon in Japan for COVID-19), why wouldn’t U.S. researchers and health authorities delve a little deeper into this antiviral therapy? Its patent has expired and now has generic status.

The U.S. is the epicenter of the COVID-19 pandemic—the highest death toll and number of cases worldwide. Although great American companies such as Regeneron and Eli Lilly are working overtime to develop compelling monoclonal antibody-based investigational products, as are the vaccine developers (Moderna, Pfizer/BioNTech, Novavax, AstraZeneca, Johnson & Johnson, etc.), could there not also be an important market for complementary and economical generic alternatives used for early stages of the viral infection?