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
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
haemophilia.1 All races and economic groups are affected
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
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
What is Hemophilia? World Federation of Hemophilia. Accessed on: 29
June 2011. Available at: www.wfh.org/2/1/1_1_Hemophilia.htm.
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.
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.