Sobi’s Elocta approved in Switzerland to treat haemophilia A

Elocta is the only recombinant factor VIII Fc fusion protein with an extended half-life approved for haemophilia A treatment in Switzerland to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

"The Swiss approval of Elocta is an important milestone for the country’s haemophilia A community, offering the potential to improve the care of people with haemophilia A," said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area head of Haemophilia at Sobi.

"Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A in Switzerland."

Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages. The Swiss 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.

Sobi and Biogen collaborate on the development and commercialisation of Elocta for haemophilia A. Sobi has final development and commercialisation rights in the Sobi territory (Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Elocta and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

About Elocta

Elocta (efmoroctocog alfa) is the first recombinant clotting factor VIII therapy in Switzerland 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.