Koronavir (medicine for treatment of COVID-19)

Main article: COVID-19 coronavirus medicine

2020

100 rubles for a tablet. FAS set a limit of the price of drugs for a coronavirus

On October 16, 2020 the Federal Antimonopoly Service (FAS) set the marginal selling price of drugs for treatment of a coronavirus of COVID-19 on the basis of a favipiravir. It will make 100 rubles for a tablet or 5500 rubles for packaging. Read more here.

Publication of final results of clinical trial

October 15, 2020 R-Pharm announced final results of clinical trial of the medicine Koronavir.

During the clinical trial conducted with participation of 168 patients with COVID-19 of an easy and medium-weight current which were observed in out-patient and hospital segments it was established that Koronavir allows to reduce time median before clinical improvement (on the Serial scale of clinical improvement of WHO) at patients with a koronavirusny infection for 4 days, and in a cohort of ambulatory patients – for 8 days.

It is important to note that for the 7th day in Koronavir's group clinical improvement occurred more, than at 50% of patients, it by 1.5 times exceeds an indicator in group of comparison in which the standard therapy including or medicines of group of chloroquine, or umifenovir in a combination with intranazalny interferon an alpha was used.

Use of the medicine Koronavir led also to statistically authentically more frequent elimination of a coronavirus of SARS-CoV-2 from mucous the rotoglotki at an early stage of a disease – i.e. for the 3 and 5 days later began therapies: for the 3rd day elimination of a virus was reached at 71.4% against 57.1% in group of comparison, on the 5th – at 81.2 against 67.9%.

Important result was also the fact that Koronavir showed a favorable profile of security. Most of patients in a research transferred therapy well, at the same time asymptomatic increase in level of uric acid (it was observed at 41.7% of patients), mainly, easy degree which was stopped after completion of therapy was the only specific ghost effect of medicine.

The publication of results of clinical trial of efficiency and Koronavir's safety in the Infektsionnye Bolezni magazine - confirmation of interest in data retrieveds from scientific community and also quality the carried-out group "R-Pharm developments.

Besides, the efficiency and security of a favipiravir (active ingredient of the medicine Koronavir) at treatment of the patients suffering from COVID-19 infection was also set during clinical trials which completion at the end of September, 2020 was announced by the Japanese corporation Fujifilm Holdings. During the conducted research with participation of 156 people it was established that clinical improvement of the patients accepting favipiravir occurs on average in 11.9 days, in group of comparison, the accepting placebos – in 14.7 days.

This difference is considered statistically significant (p = 0.0136) while the relation of risks made 1.593 (95% of DI 1.024-2.479). The research represented randomized placebo - a controlled blind comparative research that allows to refer its results to the data having high degree of substantiality.

Start of sales in drugstores

The R-Pharm group announced on September 17, 2020 registration for out-patient use of the medicine Koronavir (MNN: favipiravir), COVID-19 of an easy and medium-weight current intended for therapy of a koronavirusny infection. According to the received registration certificate (LP-006323) Koronavir became the first medicine for therapy of a koronavirusny infection in Russia which is on sale in drugstores and available to a big circle of ambulatory patients.

Final results of the clinical trial of the III phase conducted in population of patients with COVID-19 of an easy and medium-weight current which were observed in out-patient and hospital segments formed the basis for approval. During the conducted research with participation of 168 patients with COVID-19 it was established that Koronavir allows to reduce time median before clinical improvement (on the Serial scale of clinical improvement of WHO) at patients with a koronavirusny infection for 4 days, and in a cohort of ambulatory patients – for 8 days. It is important to note that for the 7th day in Koronavir's group clinical improvement occurred more, than at 50% of patients, it by 1.5 times exceeds an indicator in group of comparison in which the standard therapy including or medicines of group of chloroquine, or umifenovir in a combination with intranazalny interferon an alpha was used. Use of the medicine Koronavir led also to statistically authentically more frequent elimination of a coronavirus of SARS-CoV-2 from mucous the rotoglotki at an early stage of a disease – i.e. for the 3 and 5 days later began therapies: for the 3rd day elimination of a virus was reached at 71.4% against 57.1% in group of comparison, on the 5th – at 81.2 against 67.9%.

Important result was the fact that Koronavir showed a favorable profile of security. Most of patients in a research transferred therapy well, at the same time asymptomatic increase in level of uric acid (it was observed at 41.7% of patients), mainly, easy degree which was stopped after completion of therapy was the only specific ghost effect of medicine.

The provided results allow to consider Koronavir (favipiravir) developed by R-Pharm group, one of the most perspective medicines for therapy of a koronavirusny infection of COVID-19.

Our general task is in that the medicine which proved the efficiency was available to each person in need of the patient in it regardless of whether it undergoes treatment in a hospital or is isolated at home, – the chairman of the board of directors of R-Pharm Alexey Repik emphasized.

On the basis of data of clinical trial, at timely application of Koronavir at an initial stage of a disease, medicine showed the best among all medicines used for September, 2020 efficiency, – the director of medical department of R-Pharm Mikhail Samsonov told.

Koronavir's exit to an out-patient stage very we mean to us. Positioning of medicine on peak of virus loading will allow to avoid patients of the problems, extremely serious for a part, connected with the answer of the immune system, - Natalya Kostina, PhDs in Medicine., the chief non-staff pulmonologist of department of health care of the Voronezh region notes .

The production Koronavira organized with the assistance of Fund of development of the industry is performed at the R-Pharm enterprise in the city of Yaroslavl. All released packagings are marked by the Data Matrix codes that gives the chance to the buyer to check medicine in drugstore using mobile application Fair Sign: it will show all necessary information, including on the producer and an expiration date of medicine.

Completion of registration of Koronavir

The R-Pharm group announced on July 8, 2020 completion of process of registration of medicine for therapy of a koronavirusny infection of COVID-19 of an easy and medium-weight current - Koronavir (MNN: favipiravir). The production of medicine organized with the assistance of Fund of development of the industry will be performed at the R-Pharm enterprise in the city of Yaroslavl.

Koronavir is one of the first in Russia and the world of medicines which fights not against the complications caused by SARS-CoV-2, and directly with a virus. Medicine inhibits the virus RNA polymerase participating in replication of a virus. The efficiency of medicine is confirmed during the clinical trial conducted at patients with COVID-19 of an easy and medium-weight current which included out-patient and hospital cohorts of patients. The company notes positive effect of medicine in group of ambulatory patients: according to data retrieveds of a research, for the 7th day of therapy clinical improvement was reached at 55% of the patients receiving Koronavir while in group of comparison in which "standard" etiotropny therapy – only at 20% was applied. The significant difference by this parameter between groups remained also for the 14th day of a research, indicating that recovery at Koronavir's application, happens quicker. Koronavir effectively influenced also elimination of the SARS-CoV-2 virus: for the 5th day of application elimination occurred at most of the patients (77.5%) taking the drug. It is extremely important that portability of medicine was good: among ghost effects, mainly, reactions from digestive tract were observed and a rejection of laboratory analyses, in out-patient population all ghost effects were lungs.

Results of researches allow to consider Koronavir one of the most perspective medicines for therapy of a koronavirusny infection – COVID-19. Right after obtaining the registration certificate medicine will be sent to regions, and will begin to be applied in hospitals of Moscow, St. Petersburg, Yaroslavl, etc.

Emergence in Russia of such medicine as Koronavir, is invaluably important not only in terms of care of health of the patient. Koronavir's capability quickly to block reproduction of a virus allows to reduce the speed of its further distribution to populations and to ensure safety of people around, – the chairman of the board of directors of R-Pharm Alexey Repik notes.

The antiviral portfolio of R-Pharm was replenished with medicine for the patients suffering from an easy and medium-weight form of a course of a koronavirusny infection. The world clinical practice and the clinical trial conducted by us confirm that Koronavir promotes much faster knocking over of an infection due to effective blocking of replication of a virus, – the medical director of R-Pharm group Mikhail Samsonov emphasizes.

the Staff of scientific research institute of epidemiology of Rospotrebnadzor within clinical trial began to carry out therapy by the medicine Koronavir to patients with the confirmed koronavirusny infection since the end of May, 2020. For July, 2020 treatment within the program of clinical trial was received already by more than 110 patients, most of them were treated on an outpatient basis, for July 8, 2020 are healthy, hospitalization was not required. At many patients after the first days of use of medicine selection of a virus stopped, the expressed positive dynamics was noted: normalization or decrease in temperature, reduction of weakness and cough, improvement of objective indicators. I want to note that medicine has a favorable profile of security. The insignificant quantity of the undesirable phenomena was recorded. There is a separate wish to note that emergence of such medicine in Russia is a big step in effective fight against epidemic a koronavirusny infection, – the doctor of medical sciences, the head of department of clinical trials of scientific research institute of epidemiology of Rospotrebnadzor Tatyana Ruzhentsova says.

Medicine creation

On June 19, 2020 the R-Pharm company announced a fast exit of medicine for treatment of easy and average forms of a coronavirus of COVID-19. Innovation received the name "Koronavir".

As the director of the Yaroslavl plant of ready dosage forms (R-Pharm branch) Vladimir Kolyshkin at a meeting with the Russian President Vladimir Putin with the representatives of the industries who faced effects of spread of a coronavirus by June 19, 2020 reported medicine is on registration of the Russian Ministry of Health, and by the beginning of July is going to put on the market more than 150 thousand packagings.

Russia created medicine for treatment of easy forms of a coronavirus. Sales start in July

Kolyshkin promised that medicine will be produced at the affordable price. At the same time it did not set the price.

Koronavir is founded on the Japanese medicine "Favipiravir" on which other Russian coronavirus medicine — Avifavir is also constructed. It is recommended at the medium-weight and serious illness caused by COVID-19. Koronavir is focused on treatment of easy and medium-weight forms of a koronavirusny infection.

While at easy forms the Ministry of Health  advises  to accept hydroxychloroquine, meflokhin or interferon an alpha with umifenoviry (the last is known as the antiviral medicine Arbidol from Otisifarm). Earlier in June, 2020 WHO finally  stopped  tests of hydroxychloroquine for efficiency from a coronavirus.

At medium-weight COVID-19 forms the Ministry of Health already recommended to take other drug "R-Pharma" olokizumab, registered in May, 2020 for treatment of rheumatoid arthritis. 

In addition to Koronavir, pharmaceutical company "R-Pharm" together with  the Russian Direct Investment Fund (RDIF) create joint venture with  investment volume more than 4 billion rubles for  fight against  a new koronavirusny infection. In particular, the companies intend to be engaged in expansion of release of an olokizumab — medicine from  COVID-19 complication, and  production of vaccine.^[1]

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