Name:

Octofactor

Alternative name:

Human blood coagulation factor VIII

Type of medical product:

Protein based

Novelty:

Biosimilar

Field:

Congenital diseases

Indications for use:

Haemophilia, Type A

Status:

Registered

This protein biologic is a B-domain deleted recombinant factor VIII (FVIII). Factor VIII is required for the factor X-dependent activation by proteases, generated by internal blood clotting mechanism. The deficiency of factor VIII disturbs haemostasis and causes development of haemophilia type A. The frequency of detected haemophilia ranges from 7 to 18 per 100 000 in men (1 in 30 000 live births in boys). 87-94% of these patients have haemophilia type A.

Currently, there is approximately 5,400 patients with haemophilia are registered in the Russian Federation. Amont those 4,700 have haemophilia type A. The estimated prevalence of haemophilia in Russia is more than 8,500. Approximately 7,000 of those patients are the patients with haemophilia type A. In 60% of cases the symptoms of the disease are severe. Bleeding episodes usually begin in early childhood and can occur in any anatomical site, but mostly occurs in the joints and muscles. Recurrent bleeding leads to the disorders and deformation of joints, development of muscle contractures and atrophy.

Treatment of haemophilia A is based on the replacement therapy administered as intravenous doses of factor VIII. Development of the recombinant factor VIII is a milestone in the treatment of haemophilia A, as recombinant products have a low risk for human pathogen transmission.

The problem of blood product contamination by different viruses was highlighted in 1984, when most of the haemophilia patients in some countries (mainly the U. S.) were found to be HIV-positive because of the contaminated plasma coagulation factor concentrates. A few years after the onset of AIDS, hepatitis C virus was also identified. Research has shown that 90% of the infected patients were haemophiliacs. The problem of viral contamination and purity of the blood products helped to promote the development of recombinant coagulation factor products. However, the use of these products is limited even in developed countries due to their high costs.

A few imported recombinant factor VIII medications are registered in Russia, but the recombinant factor VIII is not available domestically. Plasmatic (non-recombinant) factor VIII is represented by imported medical products and domestic cryoprecipitate.

The human recombinant factor VIII is in our pipeline and is currently in phase II/III clinical trial.

Our Partners:

  • CJSC “Generium”