Swedish Orphan Biovitrum AB (publ) (Sobi), an international specialty healthcare company, and Biogen announced that the European Commission (EC) has approved Elocta (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway.
Elocta, a recombinant factor VIII Fc fusion protein with an extended half-life, will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.
“The EC’s approval of Elocta is an important milestone for the global haemophilia A community, offering the potential to improve the care of haemophilia A across the EU,” said Birgitte Volck, M.D., Ph.D., senior vice president of development and chief medical officer of Sobi. “Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A throughout Europe.”
Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages. The EC approval was based on data from Elocta’s pivotal, phase 3 A-LONG clinical study, which demonstrated the efficacy, safety and pharmacokinetics of rFVIIIFc 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 rFVIIIFc in previously treated male children with haemophilia A under 12 years of age. The adverse drug reactions with an incidence of = 0.5 per cent for Elocta were arthralgia, malaise, myalgia, headache and rash.
“Elocta is the first meaningful treatment advance in haemophilia A in nearly 20 years and reinforces our commitment to improving the care of people with this disease around the world,” said Gilmore O’Neill, M.D., senior vice president drug innovation units at Biogen. “Since the therapy’s approval in the United States last year, we have seen the benefits that extended protection against bleeds can offer people with haemophilia A, and we are excited to work with Sobi to make this innovative therapy available to people in Europe.”
Sobi and Biogen are collaborators in the development and commercialization of rFVIIIFc for haemophilia A. Last year, Sobi exercised its opt-in right to assume rFVIIIFc’s final development and commercialization in pre-specified territories, which essentially include Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads development and manufacturing of the product and holds commercialization rights in North America and all other regions in the world outside of the Sobi territories.
Elocta is the trade name for rFVIIIFc in Sobi’s territory, which is also approved under the name EloctaTE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the treatment of haemophilia A in the US, Canada, Australia, New Zealand and Japan.
Elocta (rFVIIIFc) is the first recombinant clotting factor VIII therapy 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). It is believed that this enables Elocta to utilize 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 utilize it in the treatment of haemophilia. Allergic type hypersensitivity reactions and development of Factor VIII neutralizing antibodies (inhibitors) may occur following administration of Elocta.