Russia Approves Avifavir For COVID-19 Treatment
The leading state news agency in the Russian Federation reported that Avifavir has received a temporary registration certificate from the Ministry of Health.
And, Avifavir has become the first Favipiravir-based drug in the world approved for the treatment of COVID-19 disease.
Avifavir, a Favipiravir-based drug, is Russia’s first COVID-19 drug and has shown high efficacy in treating patients diagnosed with COVID-19 disease during human clinical trials.
The drug is undergoing trials in Moscow, Saint-Petersburg, Tver, Nizhny Novgorod, Smolensk, Ryazan, Kazan, Ufa, and in the Republic of Dagestan.
The final stage of Avifavir clinical trials involving 330 patients, approved by the Russian Ministry of Health on May 21, 2020, is ongoing with I.M. Sechenov First Moscow State Medical University, Lomonosov Moscow State University, and other medical/academic institutions.
According to the results of the 10 days of clinical trials, Avifavir demonstrated safety with no new or previously unreported side effects detected. The median elimination of the SARS-CoV-2 coronavirus took 4-days compared to 9-days with standard therapy, according to the study.
The efficacy of the drug was reported above 80 percent, a criterion for a drug with high antiviral activity.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said in a statement: “It was developed and tested in clinical trials in Russia in an unprecedentedly short period of time, enabling Avifavir to become the first registered drug based on Favipiravir in the world.”
RDIF and the ChemRar Group said they have produced the first batch of Favipiravir.
In early June, the first batches of Avifavir will be sent to Russia's Federal Service for Surveillance in Healthcare (Roszdravnadzor) for approval for use. Deliveries of the first batches of the drug to Russian hospitals are expected on June 11, 2020.
Favipiravir was discovered by Toyama Chemical Co., Ltd., and launched sales in 2014, selectively inhibits RNA polymerase necessary for influenza virus replication.
Due to this mechanism of action, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus, SARS-CoV-2, because, like influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase.
Favipiravir undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate), which is recognized as a substrate by RdRp, and inhibits the RNA polymerase activity.
Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of anti-viral activities of favipiravir.
Previously, on February 17, 2020, Zhang Xinmin, head of the China National Center for Biotechnology Department, said that in human trials conducted in Shenzhen, Guangdong province, the anti-influenza favipiravir showed promising results against the novel coronavirus and mild adverse reactions in patients.
And on May 22, 2020, Fujifilm Holdings Corp. said it is on course to supply Avigan for 2 million COVID-19 patients by next March 2021, meeting a target set by the Japanese government to ramp up production of the potential treatment for the new coronavirus caused disease.
The US Centers for Disease Control and Prevention (CDC) is closely monitoring the worldwide outbreak of a novel coronavirus known as SARS-CoV-2, which is causing COVID-19 in humans.
The most common symptoms of COVID-19 disease are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat, or diarrhea, says the CDC.
ChemRar Group unites R&D service and investment companies in the field of innovative pharmaceuticals for the development and commercialization of innovative medicines, diagnostics, preventive care, and new treatments of life-threatening diseases in Russia and abroad.
COVID-19 treatment news published by Precision Vaccinations.
- Fujifilm announces the start of a phase II clinical trial of its influenza antiviral drug “Avigan® Tablet” for COVID-19 patients
- The first Russian drug for coronavirus Avifavir
- Russian Ministry of Health approves the first COVID-19 drug Avifavir produced by JV of RDIF and ChemRar
- Avigan Antiviral Medication