MoH approves ‘Elocta’ for treatment of haemophilia A
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STOCKHOLM, Nov 22, (Business Wire): Swedish Orphan Biovitrum AB (publ) (STO:SOBI) (Sobi) today announced that the Ministry of Health in Kuwait has approved Elocta. (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A.
Elocta is the first recombinant factor VIII Fc fusion protein therapy approved for the treatment of haemophilia A in the Middle East region. “The approval of Elocta in Kuwait is an important development for the haemophilia community in the Middle East and brings physicians, and their patients a wider range of treatment options” said Ahmad Abu-Dahab, Regional Director Middle East, & Turkey. “We will now focus on ensuring timely and sustainable access to Elocta for people living with haemophilia A across other Middle Eastern states.” Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages.
The Kuwait approval was based on data from Elocta’s pivotal, phase 3 A-LONG clinical study, which demonstrated the efficacy, safety and pharmacokinetics of efmoroctocog alfa 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 efmoroctocog alfa in previously treated male children with haemophilia A under 12 years of age.
About Haemophilia
A Haemophilia is a rare, genetic disorder in which the ability of a person’s blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with haemophilia A experience prolonged bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Prophylactic infusions of factor VIII can temporarily replace the missing clotting factors that are needed to control bleeding and prevent new bleeding episodes. The World Federation of Hemophilia recommends prophylaxis as the optimal therapy as it can prevent bleedings and joint destruction
About Elocta/Eloctate
Elocta (efmoroctocog alfa), the first recombinant clotting factor VIII therapy that offers an extended half-life in the body, is approved in the European Union, Switzerland, Iceland, Liechtenstein and Norway, as well as the United States, Canada, Australia, New Zealand, Brazil, Taiwan and Japan (as Eloctate). It was developed for haemophilia A by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This enables Elocta to use a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion technology has been used for more than 15 years, Sobi and Biogen are the first companies to utilise it in the treatment of haemophilia.
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