The First Russia COVID-19 Drug Will Deliver to the Country’s Hospitals in June

03 June 2020

GMP News

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the ChemRar Group will deliver 60,000 courses of Avifavir to Russian hospitals in June. Avifavir is Russia’s first COVID-19 drug and has shown high efficacy in treating patients with coronavirus during clinical trials. Avifavir has received a registration certificate from the Ministry of Health of the Russian Federation. Thus, Avifavir has become the first Favipiravir-based drug in the world approved for the treatment of COVID-19.

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. The high quality of Avifavir is due to more stringent requirements for its active pharmaceutical ingredient, compared with the requirements for active pharmaceutical ingredients in international markets.

Avifavir, which disrupts the reproduction mechanisms of coronavirus, is the first Russian direct-acting antiviral drug that has proven effective in clinical trials. The drug has been well studied, since it has been used in Japan since 2014 against severe forms of influenza.

The intermediate data from the Avifavir clinical trials confirm its high efficacy against COVID-19. The final stage of Avifavir clinical trials involving 330 patients, approved by the Russian Ministry of Health on May 21, 2020, is ongoing. The number of medical centers approved for the participation in Avifavir clinical trials has increased from 30 to 35 across Russia’s regions.

The drug proved to be highly effective during the clinical trials involving I.M. Sechenov First Moscow State Medical University, Lomonosov Moscow State University and other medical and academic institutions.

  • According to the results of the 10 days of the clinical trials, Avifavir demonstrated safety with no new or previously unreported side effects detected;
  • Median elimination of the virus took four days compared to nine days with standard therapy, according to the study;
  • Efficacy of the drug is above 80%, a criterion for a drug with high antiviral activity;
  • Following the first four days of treatment, 65% of the 40 patients who took Avifavir tested negative for coronavirus, which is twice as many as in the standard therapy group. By day 10, the number of patients whose tests returned negative results reached 90%;
  • The body temperature of 68% of patients taking Avifavir returned to normal earlier (on the third day) than in the control group (on the sixth day);
  • The drug is undergoing trials in Moscow, Saint-Petersburg, Tver, Nizhny Novgorod, Smolensk, Ryazan, Kazan, Ufa and in the Republic of Dagestan.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:

RDIF and ChemRar, in close collaboration with the Ministry of Health, have swiftly produced and registered a drug that surpasses its global peers not only in terms of effectiveness, but also of safety. Avifavir more than halves the duration of the disease, ensuring most patients are free of infection after the fifth day of treatment, which helps to more successfully fight the virus and protects Russian hospitals from being overwhelmed. Afivavir is not only the first antiviral drug registered against coronavirus in Russia, but it is also perhaps the most promising anti-COVID-19 drug in the world. It was developed and tested in clinical trials in Russia in an unprecedented short period of time, enabling Afivavir to become the world’s first registered drug based on Favipiravir.

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