The first Russian direct-acting intravenous antiviral drug Areplivir® (favipiravir) received marketing authorization certificate and its supply to hospitals in all regions will start by the end of the year. With its development, Promomed Group responded to the urgent need of domestic medicines for treatment of COVID-19 in hospital settings.
During a recent meeting with the leadership of the Ministry of Defense and defense industry enterprises, the transcript of which was published on the kremlin.ru portal, the President of Russia Vladimir Putin announced the appearance of new domestic drugs to combat COVID-19. The injectable dosage form of Areplivir® became one of the first such drugs.
«Until now, the only antiviral drug for parenteral administration was a foreign product, which is not only expensive, but also not readily available. Promomed Group has proposed a new class of drugs that can radically change the situation with hospitalized patients (this cohort is under the highest risk). «The appearance of an effective domestic antiviral drug for parenteral administration, widely available, can turn the tide in the fight against the pandemic,» said the chief pulmonologist of the Ministry of Health of the Russian Federation, Corresponding Member of the Russian Academy of Sciences Sergei Avdeev.
The injectable form of the drug is characterized not only by 100% bioavailability, but also by more intense penetration and distribution in cells, more and longer retention of the therapeutic concentration in tissues, as well as an improved safety profile. This will significantly increase the effectiveness of treatment at the hospital stage.
Full-scale production at the Biokhimik JSC (Promomed’s production site) and delivery to medical institutions in Russia will start in December 2021.
Petr Bely, Chairman of the Board of Directors of Promomed Group:
Earlier we found that Areplivir in tablet form performs well in the treatment of COVID-19, so we took seriously the task of creating its parenteral form for treatment at the hospital stage. We turned to the help of Russian scientists, who completed this task, and we implemented it in production. I consider it critical for the national health care to have its own development and production of innovative domestic medicines. We are pleased to do our part of work in this direction and present a drug that the doctors in the red zones are waiting and need very much.
Promomed Group was the first company in the world to make an injectable form of favipiravir, despite the fact that the substance is an insoluble powder. A multicenter clinical study led by Academician of the Russian Academy of Sciences Dmitry Pushkar confirmed the efficacy and safety of the new drug when used in hospital settings.
The oral form of Areplivir® is included in the current guidelines for both the outpatient and inpatient settings. It is expected that the injectable form will also be included in the guidelines as more effective one for the treatment of hospitalized patients when the fastest and most clinically proven result is needed. The final decision will be made by the Russian Ministry of Health at the next revision of the Interim Guidelines for prevention, diagnosis and treatment of new coronavirus infection (COVID-19).