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, a Sanofi company, 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.