Following its recent U.S. launch of Advate, Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method, (rAHF-PFM), Baxter Healthcare Corporation has signed non-exclusive multi-year agreements with several leading U.S. specialty pharmacy companies, including Accredo Health Inc, Caremark Inc, Curative Health Services and Hemophilia Resources of America to dispense Advate for the prevention and control of bleeding episodes in people with hemophilia A.
"The availability of Advate in the United States is another milestone for Baxter and the hemophilia community," said Larry Guiheen, president, Biopharmaceuticals at Baxter. "For more than a decade, Baxter has dedicated itself to increasing the supply of recombinant therapy, and today, we reaffirm that commitment by bringing a strong supply of Advate to the U.S. hemophilia community."
Advate, approved by the U.S. Food and Drug Administration (FDA) on July 25, 2003 and made commercially available in late August 2003, is the first and only recombinant factor VIII 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 infections caused by viruses that may be carried in these proteins.
Over the past 40 years, Baxter has been a leader in providing the hemophilia community with increasingly advanced clotting therapies. In the early 1990s, Baxter launched the first recombinant factor VIII therapeutic, Recombinate rAHF, which has now become the leading treatment for hemophilia A. Advate, Baxter's latest development, was a response to the National Hemophilia Foundation's Medical and Scientific Advisory Council (MASAC) recommendations that "all efforts should be made to remove human albumin from recombinant factor VIII products" and " increased efforts should be made to eliminate human and bovine proteins from the manufacturing process of recombinant products."
Advate is available as a single dose vial in four convenient potencies of 250, 500, 1,000 IU per vial and in a super-high potency 1,500 IU per vial, with a smaller infusion volume (5mL diluent), which means shorter infusion times for patients. Advate comes packaged with a 10mL syringe, butterfly bandage, alcohol swab and a patient-friendly package insert.