DEERFIELD, Ill, May 16, 2012- Baxter International Inc. (NYSE:BAX) today announced the approval of ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration (SFDA). It is estimated that more than 50,000 people in China are living with hemophilia A.
"The introduction of recombinant FVIII therapies in China offers new treatment options for hemophilia patients. The launch of ADVATE is another step in advancing hemophilia care in China," said Professor Yang Renchi, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, the leading professional hematological institution providing basic medical research with clinical services in China.
"Great strides have been made in managing hemophilia, allowing people with this serious condition to live longer, more active and fulfilling lives than ever before," said Guan Tao, Secretary General of Hemophilia Home, the hemophilia patient organization in China. "The availability of ADVATE will be an important milestone for people with hemophilia in China."
ADVATE is infused directly into the bloodstream and works by temporarily raising the level of factor VIII in the bloodstream, allowing the body's blood clotting process to properly function. Extensive global use and multiple clinical trials demonstrate clinical evidence for ADVATE. With SFDA's action, ADVATE is now approved in 54 countries worldwide.
"The approval of ADVATE in China marks an important milestone for Baxter and supports our ongoing commitment to treating individuals living with hemophilia," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business.
Baxter continues to work closely with the Chinese hemophilia community, including both patients and treaters, to provide access to care for this life-saving, life-sustaining therapy. In 2010, Baxter cooperated with the Ministry of Health to set up a "Hemophilia Disease Management System," China's first nationwide hemophilia patient registration and management system integrating diagnosis and treatment information. In recent years, Baxter has donated more than five million IUs of hemophilia products to Chinese patients and has provided a number of resources to raise awareness of the disease.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] was initially approved by the FDA in July 2003 for control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. 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.
In the United States, ADVATE [Antihemophilic Factor (Recombinant) Plasma/AlbuminFree Method] 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 the only antihemophilic factor approved in the United States for prophylactic use in both adults and children. ADVATE is not indicated for the treatment of von Willebrand disease.
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 factor VIII 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.1 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% 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 International
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.
This release includes forward-looking statements concerning expectations with respect to the introduction and use of ADVATE in China. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; market acceptance of ADVATE in China; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
1. What is Hemophilia? World Federation of Hemophilia. Accessed on: 29 June 2011. Available at: www.wfh.org/2/1/1_1_Hemophilia.htm.
2. Frequently Asked Questions About Hemophilia. World Federation of Hemophilia. Accessed on: 29 June 2011. Available at: http://www.wfh.org/2/1/1_1_1_FAQ.htm#difference.
3. Hemophilia A. National Hemophilia Foundation. Accessed on: 29 June 2011. Available at: http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=180&contentid=45&rptname=bleeding.