The European Commission has approved Swedish Orphan Biovitrum AB’s (Sobi) and Biogen’s Elocta (rFVIIIFc) for treating hemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway. Elocata, a recombinant factor VIII Fc fusion protein with an extended half-life, is indicated for both on-demand and prophylaxis treatment of people with hemophilia A of all ages.

Sobi and Biogen are collaborators in the development and commercialization of rFVIIIFc for hemophilia A. Last year, Sobi exercised its opt-in right to assume rFVIIIFc's final development and commercialization in pre-specified territories, which essentially include Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads development and manufacturing of the product and holds commercialization rights in North America and all other regions in the world outside of the Sobi territories. Elocta is the trade name for rFVIIIFc in Sobi's territory, which is also approved under the name Eloctate (antihemophilic factor (recombinant), Fc fusion protein] for the treatment of hemophilia A in the US, Canada, Australia, New Zealand, and Japan.

Elocata was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables Elocta to utilize a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion technology has been used in other therapies for more than 15 years, Sobi and Biogen are the first companies to use it in the treatment of hemophilia A, according to the companies.

Source: Biogen