Baxter Healthcare Corporation's ADVATE Achieves One Billion Unit Milestone
DEERFIELD, Ill., Jan. 31 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation, the leading global hemophilia therapy provider, announced today that accumulated sales of ADVATE(R) [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] have surpassed one billion activity units, in large part because of a rapid adoption in the United States and Europe since the therapy's launch in 2003 and 2004 respectively. The new sales figures establish ADVATE as the number one selling therapy in Baxter's hemophilia franchise, surpassing RECOMBINATE(TM) [Antihemophilic Factor (Recombinant)] as the company's leading recombinant FVIII therapy.
In addition, data from Baxter's pharmacovigilance program reaffirm ADVATE's safety profile, including a low reported incidence of inhibitor development in previously treated patients, which can be a serious complication of hemophilia management.
ADVATE is the world's first and only recombinant factor VIII therapy processed without the addition of animal or human blood components. Since the effectiveness of inactivation techniques cannot be guaranteed to eliminate future emerging pathogens, one way to eliminate the risk of blood borne pathogens for people with hemophilia is to remove these added animal and human blood components from FVIII processing.
"The rapid adoption of ADVATE indicates that pathogen risk is still a primary concern to the hemophilia community and that they understand ADVATE's properties," said Joy Amundson, president, Baxter's BioScience business.
Since the 2003 launch of ADVATE in the United States, Baxter has continually monitored safety through standard passive pharmacovigilance procedures, and shortly thereafter independently commenced an extensive active surveillance initiative, the Post Authorization Safety Surveillance program (PASS). The program is designed to capture data during a 12-month observational period from more than 400 patients with hemophilia A in the United States and Europe who are being treated with ADVATE for the first time. The ADVATE PASS program is one of the largest of its kind for people with hemophilia A.
"Data from clinical practice now indicate that ADVATE is associated with a low risk of inhibitor development," said Bruce Ewenstein, M.D., Ph.D., global medical director for hemophilia therapies at Baxter. "These data provide confirmation of the documented safety profile observed in clinical trials."
About ADVATE
ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to properly function. ADVATE is the only recombinant factor VIII therapy processed without blood or blood components, including human albumin or other plasma protein additives. ADVATE is also indicated in the perioperative management of patients with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand's disease.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing. The formation of inhibitors has been observed with all factor VIII concentrates, including ADVATE.
About Hemophilia A
People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. If untreated, patients with severe hemophilia A have a greatly reduced life expectancy. According to the World Health Organization, more than 400,000 people in the world have hemophilia, corresponding to a prevalence of 15 to 20 in every 100,000 males born worldwide.
About Baxter
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. . Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
Baxter Healthcare CorporationCONTACT: Media, Amy Cynkar, +1-847-940-5166, or Deborah Spak,+1-847-948-2349, or Investors, Mary Kay Ladone, +1-847-948-3371, or ClareSullivan, +1-847-948-3085, all of Baxter
Web site: http://www.baxter.com/