New Factor VIII Therapy for Hemophilia A Patients

New factor VIII therapy is made without any added human or animal plasma proteins and albumin in the cell culture process, purification, and final formulation, thereby eliminating the risk of infection by any viruses or pathogens in those proteins. The therapy has been cleared by the US Food and Drug Administration (FDA) for the prevention and control of bleeding episodes in patients with hemophilia A.

Called Advate, the factor VIII product is infused directly into the bloodstream of hemophilia A patients, where it temporarily raises the level of factor VIII in the blood, which allows the body's clotting process to function properly. Advate was developed by Baxter HealthCare Corp. (Deerfield, IL, USA) and is derived from the same full-length molecule as the company's Recombinate therapy. However, Advate offers greater convenience based on its higher potency and lower infusion volume, as well as removing safety concerns about viruses and infectious proteins such as HIV or hepatitis.

"While treatment options to date have provided effective disease management, there has been an acknowledged, lingering concern about the potential for viral transmission with these therapies,” said Michael Tarantino, M.D., associate professor of pediatrics at the University of Illinois and medical director of the Comprehensive Bleeding Disorder Center (Peoria, IL, USA). "Advate is the first therapy to meet this need for safety, virtually eliminating the risk of transmission of human pathogens.”




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