Baxter International Inc. : Baxter Announces FDA Approval of ADVATE 4000 IU Dosage Strength
07/16/2012| 09:05am US/Eastern
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New size expands convenience options for hemophilia A patients
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.
About ADVATE
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.
Baxter International Inc.
Media Contacts
Brian Kyhos,
(847) 948-4210
or
Investor Contacts
Mary Kay
Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085
© Business Wire 2012
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