Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Commission (EC) has approved the transfer of the marketing authorisation for Elocta® (efmoroctocog alfa) from Biogen[1] to Sobi, making Sobi the marketing authorisation holder (MAH) of Elocta in the EU.
Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days. Elocta is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A and can be used for all age groups.
As MAH Sobi will assume full legal responsibility for Elocta, from a regulatory perspective, during its entire life cycle.
The EC approval of Elocta on 19 November 2015 was based on data from the pivotal phase 3 A-LONG clinical study which demonstrated the efficacy, safety and pharmacokinetics of Elocta in previously treated males 12 years of age and older with severe haemophilia A, and from the phase 3 Kids A-LONG clinical study, which demonstrated the efficacy and safety of Elocta in previously treated boys with haemophilia A under 12 years of age.
Sobi and Biogen are collaboration partners in the development and commercialisation of Elocta for haemophilia A. Sobi holds final development and commercialisation rights in a pre-specified territory, which includes Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads development and manufacturing of the product and holds commercialisation rights in North America and all other regions in the world outside of the Sobi territory. Elocta is also approved in the U.S., Canada, Australia, New Zealand, Japan and other countries where it is known as Eloctate® (Antihemophilic Factor (Recombinant), Fc Fusion Protein).
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About Elocta®
Elocta® (efmoroctocog alfa) is the first recombinant clotting factor VIII therapy in the EU that offers an extended half-life in the body. It is indicated for the treatment and prophylaxis of bleeding episodes in patients with haemophilia A (factor VIII deficiency) and can be used by people of all ages. Elocta 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). This enables Elocta to utilise 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 utilise it in the treatment of haemophilia. As with any infused protein, allergic type hypersensitivity reactions and development of inhibitors may occur following administration of Elocta. For full prescribing information visit www.elocta.com.