ELOCTATE® [Antihemophilic Factor (Recombinant), 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, Swedish Orphan Biovitrum AB (publ) (Sobi) and Bioverativ, a Sanofi company, 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 in the United States, Canada, Australia, New Zealand, Japan, and other countries, as well as the European Union, Switzerland, Iceland, Liechtenstein, and Norway where it is approved as ELOCTA®. Allergic-type hypersensitivity reactions and development of inhibitors have been observed with rFVIIIFc ELOCTATE/ELOCTA in the treatment of hemophilia A, including in previously untreated patients.
For complete U.S. prescribing information, please visit ELOCTATE.com.