The first domestic injectable drug for the treatment of covid has been registered

This is Areplivir, which is already included in the recommendations of the Ministry of Health.

In Russia, the fourth and highest wave of coronavirus is taking place, and medicine is working with a huge overload. The registration of the first domestic direct—acting intravenous antiviral drug "Areplivir" (international nonproprietary name - favipiravir) took place on time. By the end of the year, the medicine will be delivered to hospitals in all regions. Academician of the Russian Academy of Sciences Dmitry Pushkar emphasizes: "There are two companies worldwide that produce an injectable drug with direct antiviral action against covid. And one is Russian!"

"Medicines [against covid] are currently being developed and, in principle, will be used in the near future, I am sure," President Vladimir Putin said at a meeting with the leadership of the Russian Ministry of Defense and enterprises of the Russian military—industrial complex. One of the first such drugs was the injectable Areplivir.

"Until now, the only antiviral drug for parenteral administration has been a foreign drug, which is not only expensive, but also inaccessible," explains Sergey Avdeev, chief pulmonologist at the Ministry of Health, Corresponding Member of the Russian Academy of Sciences.— Promomed He proposed a new class of drugs that can dramatically change the situation with hospitalized patients, the most risky cohort of patients." Academician Avdeev is confident that the emergence of an effective and widely available domestic antiviral drug for parenteral administration can turn the tide in the fight against the pandemic. "The injectable form of the drug is characterized not only by one hundred percent 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," concludes Sergey Avdeev.

"A clinical study has shown the advantage of using Areplivir compared to standard therapy in terms of improving clinical status," says Kira Zaslavskaya, Director of New Products at Promomed Group.— In particular, according to the study, the number of patients meeting the hospital discharge criteria (status 0-3 on the WHO categorical scale) in the Areplivir group was several times higher than in the standard therapy group. The improvement of the condition was accompanied by normalization of body temperature, the level of markers of inflammation and saturation, which indicates a positive effect of therapy on the overall prognosis."

"Clinicians have seen that Areplivir In tablets, it has proven itself well in covid therapy, so we were tasked with creating it in parenteral form for treatment at the hospital stage," comments Peter Bely, Chairman of the Board of Directors of Promomed Group.— We took this very seriously and asked for the help of Russian scientists who completed this task, and we implemented it in production. I consider it critically important for the national healthcare system to have its own development and production of innovative national medicines. We are pleased to do our part in this direction and present the drug that the doctors of the red zones are looking forward to."

"Since the beginning of December, the company has been launching commercial production and will be able to provide healthcare organizations — hospitals and hospitals," continues Peter Bely.

Promomed was the first in the world to make an injectable form of favipiravir, although the substance is an insoluble powder. A multicenter clinical trial led by Academician of the Russian Academy of Sciences Dmitry Pushkar confirmed the effectiveness and safety of the new drug when used in hospitals: "Studies on injectable Areplivir They were conducted in accordance with all the principles of GCP and evidence-based medicine, which makes it possible not to doubt the reliability of their results. It is especially important that against the background of severe coronavirus infection, the gastrointestinal mucosa is affected, which can reduce the effectiveness of oral medications. Intravenous administration eliminates this problem. In practice, the importance of having an intravenous form of the drug has been proven, which in some cases ensures a speedy recovery, having a more favorable safety profile," commented Dmitry Pushkar.

"As registration and approval procedures for the drug take place in other countries of the world, we will, of course, try to help patients all over the world," said Petr Bely.— We already know how it works with tablets — naturally, the domestic market is provided first, then the extraterritorial ones. Based on the interest we've seen in Areplivir in tablet form, about 50 countries are interested in the drug."

"The results of clinical trials will definitely be published in full, just as we did on tablets, but publications in reputable publications take time, including the work of reviewers. I would like to draw your attention to the fact that our studies on tablets are the only internationally recognized ones so far, they have been reviewed and published on ClinicalTrials.gov — It is an authoritative international resource on peer—reviewed clinical trials - and is available in the most reputable scientific sources. We are following exactly the same path with clinical studies of the intravenous form. The research team consists of two academicians of the Russian Academy of Sciences, led by Academician Dmitry Pushkar, who was awarded the Order of Pirogov for his contribution to the fight against COVID-19. The studies are carried out in strict accordance with the rules of the GCP (good clinical practice.— Kommersant-Nauka)," stated Peter Bely. These studies are an order of magnitude more complex than studies in tablet form, but their results are even more interesting to clinicians, explained the head of Promomed Group: "The full report will soon be published in Russia and internationally, and we will certainly make its results public."

The oral form of Areplivir is included in the current recommendations at both outpatient and inpatient stages. It is expected that the injectable form will also be included in the recommendations as more effective for the treatment of hospitalized patients who need the fastest and most clinically confirmed result. The final decision will be made by the Ministry of Health at the next revision of the interim guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)".

After creating the covid drug Areplivir in tablets and ampoules, the Promomed manufacturing company is thinking about developing a way to deliver the drug in the most convenient inhalation form.

"Let's not forget: the phenomenon of this coronavirus infection is that for the first time in the history of coronaviruses, the virus settles not in the upper respiratory tract, but in the lungs. And in this sense, the local delivery of medicines, not only antiviral, but also a cocktail of drugs, is seen as a very promising direction for the treatment of coronavirus and for the prevention of severe pulmonary consequences," concludes Peter Bely.

Source: www.kommersant.ru

1. https://www.kommersant.ru/doc/5077708