The Ministry of Health of Ukraine approved the research protocol for the generic drug FAVIPIRAVIR-MICROKHIM, which is planned to be released by the domestic pharmaceutical manufacturer MICROKHIM as part of the implementation of measures aimed at preventing the emergence and spread, localization and elimination of coronavirus disease (COVID-19).
The website of the Ministry of Health of Ukraine reports.
According to the procedure established by the legislation, before that, the domestic “anti-coronavirus” generic drug of “MICROKHIM” had already passed control tests in an authorized laboratory on the basis of the State Expert Center under the Ministry of Health of Ukraine.
As you know, “Favipiravir” is the international non-proprietary name of the active substance of the original antiviral drug “Avigan” (manufacturer – FUJIFILM Toyama Chemical Co., Ltd., Japan). This drug was registered in 2014 as a drug with antiviral activity against laboratory strains of influenza A and B viruses. At the same time, in September 2020, Japanese researchers received evidence of the effectiveness of Avigan’s use for treating a disease caused by coronavirus infection. It is believed that it not only eliminates the clinical manifestations of the disease, but, first of all, affects the pathogenesis of the development of the disease caused by the new coronavirus in the human body.
“We plan to conduct a study on the compliance of the bioequivalence of our drug to Avigan in December this year. If the study will be successful and approved by the State Expert Center, the drug will be registered shortly. Under such conditions, we hope that patients will receive the drug as early as the first quarter of 2021,” said Igor Pogromsky, General Director of MICROKHIM.
In addition, the head of the company noted that “in view of the high demand, the cost of a substance on the international market remains the determining factor in the price of the final product. However, the planned price of FAVIPIRAVIR-MICROKHIM will still be lower than the cost of analogues from Russia that are already actively sold on the “black market”, the price of which ranges from 2800 to 3000 hryvnia.
Therefore, taking into account the social significance of the project, the management of MICROKHIM decided at the expense of the enterprise to provide the possibility of treating the category of doctors and medical personnel with the drug, which is on the front line in the fight against coronavirus and is most susceptible to infection. For this, after the registration of the drug, the company plans, together with the Ministry of Health, to agree and implement the procedure for transferring a batch of drugs to medical institutions on a free basis. In parallel, the drug will be delivered to the pharmacy chain according to the usual procedure”.
Recall that in Ukraine, favipiravir was included in the list of drugs to prevent the spread of coronavirus disease in April 2020, which were exempted from import duties and VAT. At the same time, the drug is not registered on the territory of Ukraine, so at the moment it is impossible to buy it on the free market.