Russia’s Ministry of Health issued a temporary registration certificate announcing that Avifavir became the world’s first Favipiravir-based drug to be approved for the treatment of COVID-19. TrialSite News has reported that this class of drug has shown some promise in clinical trials in Japan; it was also being studied by Massachusetts General Hospital and Brigham and Women’s Hospital in the form of Avigan.
Now the Russia Federation has actually approved the drug based on notable efficacy in patients diagnosed with COVID-19. The drug was currently under investigation in a number of cities—from Moscow and Saint-Petersburg to Kazan and Ufa as well as the Republic of Dagestan.
TrialSite News first introduced Avigan (Favipiravir) and received many direct emails of interest all over the world including the United States. Known as Avigan, it is an antiviral drug under development by Toyama Chemical of Japan and exhibits effective activity against many RNA viruses. The drug has also been assessed in China for experimental treatment of SARS-CoV-2 and was found to be effective in treating the infection in two clinical trials in Wuhan and Shenzhen.
In fact, by February 17, 2020, the head of the China National Center for Biotechnology Department, Zhang Xinmin, reported that the drug showed favorable anti-influenza qualities based on clinical trials in Shenzhen, Guangdong province reported Precision Vaccinations.
Avigan has evidenced activity against influenza viruses, West Nile virus, yellow fever virus, foot and mouth disease and others.
The global manufacturer and intellectual property owner is Japan’s Fujifilm Holdings Corp and its subsidiary Fujifilm Toyama Chemical Co., Ltd. The Japanese company has a mandate from the Japanese government to produce up to 2 million doses for COVID-19 patients by March 2021 as part of the war on the COVID-19 pandemic.
In Russia, the drug trials were supported by a couple companies, including the ChemRar Group and RDIF who led local production of the drug. Apparently, ChemRar Group combines R&D services, drug development investment, manufacturing and commercialization to help improve care and prevent life-threatening diseases in Russia and abroad. Investment fund RDIF owns 50% of drug maker ChemRar and helped fund the studies, totaling about 300 million rubles ($4.3 million).
The last decisive Russian Ministry of Health-approved clinical trial included 330 patients and is led by I.M. Sechenov First Moscow State Medical University, Lomonosov Moscow State University and other centers. Based on recent news out of Russia, after just ten days into the study the drug evidenced safety with no new side effects or adverse events.
The drug has showed a median cut of the median duration of the illness by over half from 9-days with standard therapy down to 4-day with the investigational drug Avifavir. With an 80% efficacy and evidence of high antiviral effect, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), reported, “It was developed and tested in clinical trials in Russia in an unprecedented short period of time, enabling Avifavir to become the first registered drug based on Favipiravir in the world.”
A review of Clinicaltrials.gov reveals at least 20 ongoing or planned clinical trials involving the use of Favipiravir in association with COVID-19 patients.
Now that the drug has a formal government approval, the first production batches will be distributed to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for approval of use. The authorities are planning to actually have the drug ready for use by Russian hospitals by June 11, 2020.