ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant clotting factor IX therapy with prolonged circulation in the body, was developed for hemophilia B using Fc fusion technology. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling ALPROLIX to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). While Fc fusion technology has been used for more than 15 years, Bioverativ and Sobi have optimized the technology and are the first companies to utilize it in the treatment of hemophilia.
ALPROLIX is manufactured using a human cell line in an environment free of animal and human additives.
ALPROLIX is approved and available for use for the treatment of Hemophilia B 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 ALPROLIX in the treatment of hemophilia B, including in previously untreated patients.