The European Commission has approved the transfer of the marketing authorisation for Elocta® (efmoroctocog alfa) from Biogen to Sobi, making Sobi the marketing authorisation holder 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).