FDA approval of Bayer kogenate FS for routine prevention of hemophilia A

Source: Biovalley announced on May 13, 2014 that the new indication of anti hemophilia factor VIII (recombinant) kogenate FS was approved by FDA for routine prevention of adult patients with hemophilia A A, so as to prevent or reduce the frequency of bleeding attack The approval of this new indication is based on positive data from the spinart study The study was carried out in adult patients with hemophilia A A and reached the primary end point of efficacy and safety Previously, kogenate FS has been approved for use in adults and children with hemophilia A to prevent bleeding When used as routine prophylaxis, kogenate FS reduces the number of bleeding episodes in adults and children, and reduces the risk of joint injury in children Kogenate FS is not suitable for the treatment of von Willebrand disease Kogenate FS is a recombinant clotting factor VIII, which is used to replace endogenous clotting factor VIII, which is absent in hemophilia A Hemophilia is a kind of hereditary hemorrhagic disease caused by the lack of coagulation factor Ⅷ or ⅸ, or the abnormal function of coagulation factor Ⅷ or ⅸ Factor VIII deficiency is called hemophilia A, factor IX deficiency is called hemophilia B, patients need lifelong treatment Its prevention and treatment are mainly used coagulation factor replacement therapy Kogenate FS is the second generation recombinant gene engineering product expressed by the host cell of BHK-21 (baby hammer kidney cell), which has been listed in the United States and the European Union Kogenate-FS is composed of 2351 amino acids and contains 25 N-glycosylation sites It is a glycoprotein with full-length sequence of factor Ⅷ modified by glycosylation.