Human blood coagulation factor IX
Type of medical product:
Indications for use:
Haemophilia, Type B
This medication is a human recombinant coagulation factor IX. Factor IX circulates the blood as an inactive precursor of vitamin K-dependent serine protease, involved in the blood coagulation cascade. Coagulation factor IX deficiency causes haemophilia type B. The incidence of this type of haemophilia is 1 in 30,000 in men. Haemophilia is accompanied by frequent and recurring bleeding episodes that may require immediate clinical intervention and can be life-threatening and lead to the delayed debilitating effects (disorders of the joints, muscles, bones and skeleton). Even a single bleeding in the joint can cause the development of irreversible changes that can lead to disability. The risk of bleeding depends on the concentration of the factor IX in the blood stream. Moderate and severe conditions are found in
Treatment of patients with haemophilia B is based on the regular injections of Factor IX. Unfortunately, until recently, blood coagulation factors obtained from donor blood were used for the treatment of patients with haemophilia. As a result, there was a high probability of viral infection in patients (mostly with hepatitis B and C).
In the developed countries, this problem was solved by the use of recombinant coagulation factor IX. Currently, recombinant coagulation factor IX is not available in Russia. We are proud that our company has developed and implemented a full cycle production of the recombinant coagulation factor IX in Russia. Our efforts will make this therapeutic product available for patients in need and hopefully will help to improve the quality of care in the Russian Federation through the manufacturing of a safer recombinant product. It will also help to reduce the dependence of our country on the foreign medical products.
We have recently successfully completed a phase I clinical trial of this product.