First paediatric patients with severe haemophilia A started to receive treatment with Eutoplasm (blood clotting factor VIII) as part of an international multicentre clinical trial at Morozovskaya Hospital in Moscow. The study will also include treatment of children at Podolsk Regional Clinical Hospital in the Moscow Region and at the Republican Specialised Scientific and Practical Centre of Haematology in Tashkent (Republic of Uzbekistan).

Currently the trial is being conducted in older children (6–12 years of age). After confirmation of efficacy and safety in children over 6 years of age, the study will be continued in children of the younger age group (under 6 years old).

Completion of the clinical trial is scheduled for 2026.

Eutoplasm was registered in the Russian Federation in 2023 (Marketing Authorisation ЛП-№(002279)-(РГ-RU)) for treatment and prevention of bleeding in patients over 12 years of age with congenital haemophilia A or acquired deficiency of blood coagulation factor VIII. Efficacy and safety of Eutoplasm was confirmed within the framework of an international multicentre clinical study conducted in accordance with requirements of the European Medicines Agency (EMA) in adults and children over 12 years of age in Russia and Uzbekistan.

Eutoplasm is produced in dosages of 500 IU and 1,000 IU at the Pharmstandard‑UfaVITA Plant in Ufa using full-cycle technology from highly purified human blood plasma cryoprecipitate. The enterprise reached full production capacity with regard to Eutoplasm (blood coagulation factor VIII) at the end of 2023. The drug is produced using chromatographic purification methods allowing to obtain high-purity blood coagulation factor VIII, as well as modern methods of virus inactivation completely eliminating the risk of viral infections transmission through the product. Currently, the drug is supplied under the 14 Nosologies programme.