Russian Ministry of Health included injectable Areplivir® in the guidelines for the treatment of COVID-19 on December 27, 2021. The first batch of the drug was dispatched from the plant on the same day.
The Ministry of Health of the Russian Federation has included the injectable form of the direct-acting antiviral drug Areplivir®(favipiravir) in the updated, fourteenth, version of the interim guidelines «Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)» released on December 27, 2021. On the same day, the first batch of the drug was shipped from the Biokhimik plant (member of Promomed Group). In total, by the end of the year, Promomed Group plans to deliver about 300 thousand doses of the drug to hospitals in the country. The first original domestic direct-acting antiviral drug Areplivir®for intravenous administration received marketing authorization certificate on November 12, 2021 and remains the most anticipated drug for patients hospitalized with COVID-19.
«In the face of a heavy burden of new strains of coronavirus infection, not only clinical, but also pharmacoeconomic advantages of the new form of Areplivir are very important. Until now, the use of antiviral infusions was possible only with the use of a certain foreign product; for a number of reasons, its availability for many medical institutions was a problem. The domestic drug with proven efficacy is designed to turn the tide of the pandemic,» commented Dmitry Pushkar, Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, member of the Academic Consortium of the Academic Commonwealth for the Study of COVID-19.
Sergey Avdeev, Chief Pulmonologist of the Russian Ministry of Health, Corresponding Member of the Russian Academy of Sciencesdraws attention to the fact that «The injectable form of the drug is characterized not only by 100% bioavailability, but also by more intense penetration and distribution in cells, a longer maintenance of therapeutic concentration in tissues, as well as an improved safety profile. This should significantly increase the efficacy of treatment at the hospital stage.»
The efficacy and safety of Areplivir®in the form for parenteral administration have been proven in a multicenter comparative clinical study led by D.Yu. Pushkar.
Larisa Balykova, Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Director of the Medical Institute, Head of the Department of Pediatrics at the Ogarev Mordovia State University, commented the results of the study as follows: «We compared the results of therapy in groups of patients hospitalized with COVID-19 who received either favipiravir as an intravenous infusion or standard therapy (oral antiviral drugs or a foreign injectable drug). The hypothesis of superiority of parenteral Areplivir has been proven for the selected endpoints. In particular, in the investigational drug arm, a significant improvement in the clinical status of patients, even those with risk factors, for example, patients over 60, was observed more than twice as often and the period to achieve this was shortened two times as compared to control arm. As early as after 10 days of treatment, more than 90% of patients (as compared to 62.04% in the control arm) met the criteria for discharge from the hospital.»
Thus, studies have shown that Areplivir in injectable form allows for a faster and more pronounced therapeutic effect and increases the effectiveness of therapy, which reduces the risk of developing an extremely severe course of the disease, helps to discharge patients from hospitals earlier and improve the prognosis.
The pharmaceutical company Biokhimik of Promomed Group, which has been producing Areplivir®in tablet form since mid-2020, has prepared the plant's production facilities for the uninterrupted supply of the parenteral dosage form according to numerous requests from doctors. «During the January holidays, when all people will have a rest, most of our employees will continue their work, just like doctors. Now, when the new dosage form has received the status of recommended treatment for COVID-19, our primary task is to provide this vital drug to the red zones of hospitals,» said Maxim Smagin, CEO of Promomed.
Promomed was the first in the world to develop a complex unique technology for dissolving favipiravir and preparing preparations for parenteral use on the basis of this technology. It is notable that the substance is an insoluble powder.
Elena Simakina, Head of the Infectious Diseases Department of Clinical Hospital No. 1, cand. med. sci.noted: «Unfortunately, the number of hospitalized patients remains high. For such patients, the highest possible bioavailability of the active substance, fast action and a high safety profile are extremely important. Of particular note, the use of parenteral form of Areplivir is convenient for patients who have to stay in prone position. The intravenous form of the new antiviral drug meets all the requirements, this is exactly what we need to work in the red zone.»