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.
About ADVATE
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 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.
- 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.
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