Biogen Idec Receives FDA Approval for Hemophilia Drug EloctateBy
The Food and Drug Administration has approved Biogen Idec’s Eloctate (antihemophilic factor (recombinant), Fc fusion protein), for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding .
Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Eloctate consists of the Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to a protein fragment, Fc, which is found in antibodies. This makes the product last longer in the patient's blood.
Hemophilia A is a rare, chronic, genetic disorder in which the ability of a person's blood to clot is impaired. This can lead to recurrent and extended bleeding episodes. Eloctate received orphan-drug designation for this use by the FDA because it is intended for treatment of a rare disease or condition.
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of Eloctate for hemophilia A and Alprolix for hemophilia B. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions in the world, excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe, Russia, the Middle East, and Northern Africa.
Eloctate 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 Eloctate 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, Biogen Idec says it is the only company to apply it to the treatment of hemophilia.
Source: FDA and Biogen Idec