Russian drug with proven clinical efficacy against coronavirus registered in Indonesia
Avifavir became the world’s first favipiravir-based drug approved for the treatment of coronavirus, and the first drug registered in Russia against coronavirus
Moscow, March 24, 2021 — The Russian Direct Investment Fund (RDIF), the sovereign wealth fund of the Russian Federation, and the ChemRar group of companies announce the receipt of a registration certificate from the Indonesian Medicines and Foods Control Agency (NADFC) for a Russian drug against the Avifavir coronavirus (INN: favipiravir).
ChemRar Group of Companies is the largest manufacturer of an anti-coronavirus drug in Russia. Avifavir ® (INN: favipiravir) is the first drug in Russia approved for use against coronavirus, and the first drug registered in the world with the active ingredient favipiravir as an indication for the treatment of coronavirus. The drug is included in the VED list and guidelines of the Russian Ministry of Health for the prevention, diagnosis and treatment of new coronavirus infection.
Registration of Avifavir in Indonesia was carried out according to an accelerated procedure based on data from an extended phase II-III clinical trial, which took place in compliance with the GCP rules from April to September 2020 in 30 specialized centers throughout Russia with the participation of 460 patients.
According to the research results, Avifavir has demonstrated high efficiency in the complex treatment of patients hospitalized with a new coronavirus infection, in particular:
The median elimination of the virus in patients is 4 days instead of 9 with standard therapy;
Efficiency is above 80%, which is the criterion for a drug with high antiviral activity;
The study showed a favorable safety profile in all studied groups.
In addition, continuous monitoring of data on the use of the drug «Avifavir» in clinical practice, which currently reliably confirm the results obtained in the course of the clinical trial, is carried out.
Pratapa Nirmala (Fahrenheit) is the partner for the registration and sale of Avifavir in Indonesia.
Since the beginning of June 2020, Avifavir ® has been supplied to all regions of the Russian Federation. The drug is also supplied to 15 countries of the world.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said:
“The registration of Avifavir in Indonesia, one of the most populous countries in Asia, is an important step in providing the national health system with the leading anti-coronavirus drug. Experts in Indonesia have shown high confidence in the drug, which is registered without additional clinical trials in the country. «Avifavir» significantly reduces the recovery time and has a high efficiency, which allows faster treatment of patients and significantly reduces the burden on medical institutions. «
Irina Tyrnova, General Director of Research Institute «ChemRar», noted:
Avifavir is the world’s first high-quality drug based on favipiravir, the effectiveness of which against COVID-19 has been thoroughly studied and proven in a large-scale clinical trial. All studies were carried out in accordance with the relevant international rules, including the requirements for the preparation of reporting documents, as a result of which our foreign partners successfully obtain permission from the regulatory authorities to import and use the drug on the territory of almost any country. We hope that in the near future we will start supplying the drug with our partner Fahrenheit, and patients in Indonesia will have access to effective therapy with Avifavir, one of the most effective and well-studied in the world today. «