Novo Nordisk has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of long-acting factor IX, nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor IX with an extended half-life intended for replacement therapy for patients with hemophilia B.

Glycopegylation, the prolongation technology used for the half-life extension, is a new approach in hemophilia B, according to Novo Nordisk. It is already used in treating hemophilia A and other therapeutic areas.

In related news, the European Commission has approved Swedish Orphan Biovitrum AB’s (Sobi) and Biogen’s Alprolix (rFIXFc), their extended half-life therapy, for the treatment of hemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is a recombinant factor IX Fc fusion protein therapy for hemophilia B.

Alprolix is currently approved for the treatment of hemophilia B in the United States, European Union, Canada, Japan, Australia, New Zealand, and other countries, to provide prolonged protection from bleeds. Alprolix is a recombinant clotting factor therapy developed for hemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This technology enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion has been used for more than 15 years, Sobi and Biogen said that they are the first companies to utilize it in the treatment of hemophilia.

Sobi and Biogen collaborate on the development and commercialization of Alprolix for hemophilia B. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialization rights in North America and all other regions in the world excluding the Sobi territory.Earlier this month, Biogen announced that it intends to spin off its hemophilia business as an independent, publicly traded company. The new company, to be named at a later date, will focus on the discovery and development of therapies for the treatment of hemophilia, with existing marketed products to include Eloctate and Alprolix, indicated for the treatment of hemophilia A and B, respectively. The new company is expected to continue to develop and commercialize Eloctate and Alprolix under Biogen’s existing collaboration agreement with Sobi. Eloctate and Alprolix generated combined revenues of $640 million during the twelve-month period ended March 31, 2016.

Source: Novo Nordisk