Biogen Idec and Swedish Orphan Biovitrum (Sobi), a  biopharmaceutical company based in Stockholm, report that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) of Elocta (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of hemophilia A. The validation of the MAA initiates the EMA's review process.

Elocta is the European trade name for rFVIIIFc, which is also known as Eloctate [antihemophilic factor (recombinant), Fc fusion protein] in the US, Canada, and Australia, where it is approved for the treatment of hemophilia A. Eloctate is a recombinant clotting factor VIII therapy with prolonged circulation to provide protection from bleeding episodes with the potential for an extended interval between prophylactic injections. Elocta is an investigational, recombinant clotting factor therapy developed for hemophilia A by fusing 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 use a naturally occurring pathway to prolong the time therapy remains in the body. While Fc fusion has been used for more than 15 years, Biogen Idec says it is the only company to apply it to the treatment of hemophilia.

Biogen Idec and Sobi are collaborators in the development and commercialization of Eloctate/Elocta for hemophilia A. Sobi has an opt-in right to take over final development and commercialization of Elocta for the Sobi territories (Europe, North Africa, Russia, and most Middle Eastern markets). Biogen Idec leads development for Eloctate/Elocta, has manufacturing rights, and has commercialization.

Source: Biogen Idec