DEERFIELD, Ill., JULY 16, 2012 - Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes in patients with hemophilia A. The new 4000 IU dosage strength provides the convenience of a single vial dosing opportunity for many adult patients, including some patients on a dosing schedule of every three days for prophylactic treatment with ADVATE.
This approval extends Baxter's portfolio of hemophilia treatments, and makes Baxter the only company to offer a 4000 IU dosage. This broad selection of 11 dosages enhances convenience for patients by offering the opportunity to use a single vial rather than infusing multiple vials of therapy. The 4000 IU will be available to patients in the United States in August.
"The 4000 IU dose is particularly well-suited for patients on an every three-day prophylaxis regimen," said Bruce Ewenstein, M.D., Ph.D, vice president, clinical affairs, Baxter's BioScience business.
In December 2011, ADVATE was approved by the U.S. FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A, becoming the only antihemophilic recombinant FVIII treatment approved in the U.S. for prophylactic use in both adults and children (0-16 years). The approval was based on Phase IV data showing that routine prophylaxis of ADVATE significantly reduced median annual bleed rates (ABR) in hemophilia A patients from 44 to one as compared to an on-demand regimen, a 98 percent reduction in ABR. 42 percent of patients experienced no bleeding episodes while on one year of prophylactic treatment.
The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII. The most common adverse reactions observed in clinical trials (frequency > 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.
ADVATE is approved in the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau, Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.
About Hemophilia A
Hemophilia is a rare genetic blood clotting disorder that primarily affects males.1 People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.1 Two of the most common forms of hemophilia are A and B.2 In people with hemophilia A, clotting FVIII is not present in sufficient amounts or is absent.2 Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.2 According to the World Federation of Hemophilia, more than 400,000 people in the world have hemophilia.2 All races and economic groups are affected equally.1
Detailed Important Risk Information for ADVATE
ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product.
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesia, rash, flushing, face swelling, urticaria, dyspnea, and pruritus. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).
If expected plasma FVIII levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures FVIII inhibitor concentration.
The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII.
The most common adverse reactions observed in clinical trials (frequency greater than or equal to 10 percent of patients) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.
Please see full prescribing information for ADVATE at: www.baxter.com/downloads/healthcare_professionals/products/ADVATE_PI.pdf
About Baxter in Hemophilia
For more than 60 years, Baxter has been dedicated to advancing hemophilia care by introducing a series of therapeutic firsts for people with hemophilia. Baxter has developed the broadest portfolio of hemophilia treatments in the industry, providing a range of options to benefit clinicians and patients living with hemophilia A and B. Our work is focused on optimizing hemophilia care and improving the lives of people living with hemophilia worldwide.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
1. What is Hemophilia? World Federation of Hemophilia. Accessed on: May 24, 2012. Available at: www.wfh.org/2/1/1_1_Hemophilia.htm.
2. Frequently Asked Questions About Hemophilia. World Federation of Hemophilia. Accessed on: May 24, 2012. Available at: http://www.wfh.org/2/1/1_1_1_FAQ.htm.