Biogen Idec and Swedish Orphan Biovitrum AB (publ) (Sobi) today announced 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 U.S., Canada, and Australia, where it is approved for the treatment of hemophilia A. Eloctate is the first recombinant clotting factor VIII therapy with prolonged circulation to provide protection from bleeding episodes with the potential for an extended interval between prophylactic injections.

“The validation of Elocta's application by the EMA is an important step toward bringing this innovative treatment to people with hemophilia A in Europe,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “Elocta has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections.

For more details, go to: http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2402&M=NewsV2&PID=61997