WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration granted approval for Coagulation Factor VIIa (Recombinant) to biopharmaceutical company LFB S.A. for the treatment and control of bleeding episodes occurring in adults and adolescents - 12 years of age and older- with hemophilia A or B with inhibitors. It is marketed as Sevenfact by LFB.
Sevenfact provides additional treatment option for the control of bleeding episodes in adults and adolescents with hemophilia who have developed inhibitors.
Sevenfact is claimed to be the first product for hemophilia treatment that contains an active ingredient obtained from genetically engineered rabbits to produce a protein necessary for blood coagulation.
Hemophilia A or B is a congenital bleeding disorder caused by a dysfunction or deficiency of Coagulation Factor (F) VIII or IX, respectively. Patients with hemophilia may bleed for a longer time than others after injury or surgery, and may also have spontaneous bleeding in muscles, joints and organs, which may be life-threatening.
According to the Centers for Disease Control and Prevention (CDC), an estimated 20,000 people are living with hemophilia in the United States. Bleeding episodes in these individuals are managed by either on-demand treatment or prophylaxis using products containing FVIII or FIX.
The administration of products such as Sevenfact, which bypass the Factor VIII and Factor IX reactions, promotes clot formation and controls bleeding.
The safety and efficacy of Sevenfact were determined using data from a clinical study that evaluated 27 patients with hemophilia A or B with inhibitors, which included treatment of 465 mild or moderate, and three severe bleeding episodes.
Another study evaluated the safety and pharmacokinetics of three escalating doses of Sevenfact in 15 patients with severe hemophilia A or B with or without inhibitors.
However, Sevenfact is not indicated for patients with known allergy or hypersensitivity to rabbits or rabbit proteins.
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