JSC “Pharmstandard” has registered a domestic Plasma-Derived Coagulation Factor VIII for the treatment of Haemophilia A under trademark “Eightoplasm” . The product was developed as part of the state strategy for increasing the population’s life expectancy and quality of life and improving medicine availability. Its manufacturing was launched at the end of 2022 at the facilities of JSC “Pharmstandard-UfaVITA” plant in the city of Ufa. Currently, the enterprise has reached full production capacity and is arranging to supply the product to the Russian market.
This is the first facility in the country to operate the large-scale, full-cycle manufacturing of Human Plasma-Derived Coagulation Factor VIII, starting with the initial raw material: cryoprecipitate. Its suppliers are major certified European companies managing donors from Europe and the USA: Sanquin (Netherlands) and Kedrion (Italy). Each lot delivered to the Russian Federation has a customs cargo declaration and undergoes all the necessary stages of inspection and tracking.
Within the manufacturing of the finished medicinal product, advanced chromatographic purification methods are applied, which make it possible to obtain Blood Coagulation Factor VIII of high purity, as well as state-of-the-art methods of viral inactivation, which completely eliminate the risk of transmitting viral infections through the product.
The efficacy and safety of Eightoplasm have been proven within the international multi-center clinical studies conducted in compliance with the requirements of the European Medicines Agency (EMA). The study results demonstrate that it is possible to use the product both for preventing spontaneous and post-traumatic bleeding and for reducing blood loss during surgical interventions of varying degrees of complexity in patients with severe haemophilia A. Specifically, 10 surgical interventions were performed over the course of the studies, including 9 planned inpatient interventions and 1 emergency outpatient intervention. In all 10 patients, intra-operative blood loss was less than or equal to the mean estimated blood loss for the type of procedure in a patient with normal haemostasis and of the same sex, age, and height. The product administration did not lead to any allergic reactions, thrombotic and thromboembolic complications, or formation of inhibitory antibodies to factor VIII. It is important to note that the study results are not inferior to foreign counterparts, including ones in surgical interventions.
At the same time, the registered maximum selling price for the product is 8% lower compared to the blood coagulation factor VIII products by foreign manufacturers that are currently in circulation in Russia, which will allow optimizing government costs for therapy.
