ELOCTATE® [Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein], the first recombinant clotting factor VIII therapy with prolonged circulation in the body, was developed for hemophilia A using Fc fusion technology. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling ELOCTATE to use a naturally occurring pathway to extend the time the therapy remains in the body. While Fc fusion technology has been used for more than 15 years, Bioverativ, a Sanofi company, and Sobi have optimized the technology and are the first companies to utilize it in the treatment of hemophilia.
ELOCTATE is manufactured using a human cell line, using an environment free of animal and human additives.
ELOCTATE is approved and available for use for the treatment of Hemophilia A in Canada. It is also approved in the United States, Japan, Australia, New Zealand, and other countries. Allergic-type hypersensitivity reactions and development of inhibitors have been observed with rFVIIIFc ELOCTATE in the treatment of hemophilia A, including in previously untreated patients.