Expert RA upgraded PROMOMED DM's credit rating to ruA
27.12.2021
27.12.2021
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 "On the prevention, diagnosis and treatment of novel coronavirus infection (COVID - 19)", released on December 27, 2021. On the same day, the first batch of the drug was shipped from the Biochemik plant (part of the Promomed group of companies). In total, Promomed Group plans to send about 300,000 doses of the drug to hospitals in the country by the end of the year. The first original domestic direct-acting antiviral drug Areplivir® for intravenous administration received a registration certificate on November 12, 2021 and remains the most anticipated remedy for patients hospitalized with COVID-19.
"Given the heavy burden of new strains of coronavirus infection, not only the clinical but also the pharmacoeconomic advantages of the new form of Areplivir are extremely relevant. Until now, the use of antiviral infusions was possible only with the use of a single foreign drug, which for a number of reasons greatly reduced its availability to many medical institutions in the country. A domestic drug with proven efficacy is designed to reverse the course of the pandemic," said Dmitry Pushkar, Academician of the Russian Academy of Sciences, MD, Professor, member of the academic consortium of the Academic Community for the study of COVID-19.
Sergey Avdeev, Chief pulmonologist at the Ministry of Health of the Russian Federation, Corresponding Member of the Russian Academy of Sciences, draws attention to the fact that "The injectable form of the drug is characterized not only by 100% bioavailability, but also by more intensive penetration and distribution in cells, longer retention of therapeutic concentration in tissues, and an improved safety profile. This should significantly increase the effectiveness of the treatment at the hospital stage."
As part of a multicenter comparative clinical trial led by D.Y. Pushkar, the efficacy and safety of Areplivir® in parenteral form were confirmed.
"We compared the results of therapy in groups of patients hospitalized with COVID-19 who received either favipiravir in the form of intravenous infusions or standard therapy (oral antiviral drugs or a foreign injectable drug). The hypothesis of the superiority of Areplivir therapy for parenteral use has been proven by the selected endpoints. In particular, against the background of a course of therapy with the investigational drug, a significant improvement in the clinical status of patients, even those with risk factors, for example, patients over 60 years of age, is observed more than twice as often and twice as quickly. After 10 days of therapy, more than 90% of patients (compared with 62.04% in the comparison group) met the criteria for hospital discharge," Larisa Balykova, Corresponding Member of the Russian Academy of Sciences, MD, Professor, Director of the Medical Institute, Head of the Department of Pediatrics of the Moscow State University, shared the results of the study. N. P. Ogareva.
Thus, studies have shown that the use of Areplivir in injectable forms can provide a faster and more pronounced therapeutic effect and increase the effectiveness of therapy, which reduces the risk of developing an extremely severe course, accelerates patient discharge and improves prognosis.
The pharmaceutical company Biochemist of the Promomed Group of companies, which has been producing Areplivir® in tablet form since mid-2020, has prepared the plant's production facilities for the uninterrupted supply of the drug for parenteral administration according to numerous medical requests. "During the January holidays, when the country is on vacation, most of our employees, as well as doctors, will remain at their jobs. Now that the new dosage form has received the status of recommended for the treatment of COVID-19, our primary task is to provide the red areas of hospitals with a vital drug," said Maxim Smagin, CEO of Promomed.
Promomed was the first in the world to develop a complex and unique technology for the dissolution of favipiravir and the preparation of parenteral drugs based on it. Despite the fact that the substance is an insoluble powder.
Elena Simakina, Head of the Infectious Diseases Department of Clinical Hospital No. 1, PhD noted: "Unfortunately, the number of hospitalized patients remains high. For such patients, the highest possible bioavailability of the active substance, rapid action and a high safety profile are extremely important. It is worth noting that the use of the parenteral form of Areplivir is convenient for patients who are forced to constantly be on their stomach. The intravenous form of the new antiviral drug meets all the necessary requirements, which is exactly what we need to work in the red zone."
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