Baxter International Inc. (NYSE:BAX) today announced positive
results from its Phase III clinical trial evaluating the safety and
efficacy of BAX 817, an investigational recombinant factor VIIa
(rFVIIa) treatment for people with hemophilia A or B who develop
inhibitors.
The prospective, open-label, randomized, multicenter trial was
designed to assess the safety and efficacy of BAX 817 in male
patients ages 12 to 65 with hemophilia A or B with inhibitors over
a 6-month period using on-demand therapy. The trial met its primary
endpoint of successful resolution of acute bleeding episodes at 12
hours with both on-demand treatment regimens, dosing either 3x90
µg/kg or 1x270 µg/kg, with an overall success rate of 92 percent
(98 percent and 85 percent in each dosing group, respectively).
Further, 89 percent of patients in the trial achieved sustained
bleeding control for all acute bleeding episodes 24 hours
after infusion.
''The development of inhibitors remains one of the most
significant challenges in treating hemophilia, as it may place
patients at increased risk for life-threatening complications
resulting from difficult-to-treat bleeding episodes,'' said John
Orloff, M.D., vice president and global head of research and
development at Baxter BioScience. ''These positive results reflect
our commitment to addressing the complex treatment of hemophilia
patients with inhibitors, and reinforce our legacy of advancing
hemophilia care worldwide.''
No patients developed inhibitors or binding antibodies to BAX
817, and none discontinued treatment due to an adverse event (AE).
One patient was hospitalized following a traumatic muscle bleed
that did not respond to BAX 817. Non-serious AEs observed in the
trial were generally consistent with the underlying disease or
other etiology, and were all deemed to be unrelated to
treatment.
Full data from the trial, including additional efficacy and
safety outcomes, will be presented at a medical meeting later in
2015. The company plans to initiate regulatory submissions aligned
to manufacturing expansions currently underway. Baxter remains
committed to advancing our portfolio in inhibitor management. If
approved, BAX 817 would broaden the existing portfolio of
hemophilia and inhibitor treatments within Baxter’s
biopharmaceutical business, including FEIBA [Anti-Inhibitor
Coagulant Complex] and the recently approved OBIZUR [Antihemophilic
Factor (Recombinant), Porcine Sequence] for acquired hemophilia
A.
About FEIBA
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use
in hemophilia A and B patients with inhibitors for:
• Control and prevention of bleeding episodes
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of
bleeding episodes.
FEIBA is not indicated for the treatment of bleeding episodes
resulting from coagulation factor deficiencies in the absence of
inhibitors to coagulation Factor VIII or coagulation Factor IX.
Detailed Important Risk Information
WARNING: THROMBOEMBOLIC EVENTS
• Thromboembolic events have been reported during
post-marketing surveillance, particularly following the
administration of high doses and/or in patients with thrombotic
risk factors.
• Monitor patients receiving FEIBA for signs and
symptoms of thromboembolic events.
The use of FEIBA is contraindicated in patients with:
• Known anaphylactic or severe hypersensitivity reactions to
FEIBA or any of its components, including factors of the kinin
generating system
• Disseminated intravascular coagulation (DIC)
• Acute thrombosis or embolism (including myocardial
infarction)
Thromboembolic events (including venous thrombosis, pulmonary
embolism, myocardial infarction, and stroke) can occur with FEIBA,
particularly following the administration of high doses (above 200
units per kg per day) and/or in patients with thrombotic risk
factors.
Infusion of FEIBA should not exceed a dose of 100 units per kg
body weight every 6 hours and daily doses of 200 units per kg body
weight. Monitor patients receiving more than 100 units per kg of
body weight of FEIBA for the development of DIC, acute coronary
ischemia and signs and symptoms of other thromboembolic events. If
clinical signs or symptoms occur, such as chest pain or pressure,
shortness of breath, altered consciousness, vision, or speech, limb
or abdomen swelling and/or pain, discontinue the infusion and
initiate appropriate diagnostic and therapeutic measures.
Hypersensitivity and allergic reactions, including severe
anaphylactoid reactions, can occur following the infusion of FEIBA.
The symptoms include urticaria, angioedema, gastrointestinal
manifestations, bronchospasm, and hypotension. These reactions can
be severe and systemic (e.g., anaphylaxis with urticaria and
angioedema, bronchospasm, and circulatory shock). Other infusion
reactions, such as chills, pyrexia, and hypertension have also been
reported. If signs and symptoms of severe allergic reactions occur,
immediately discontinue administration of FEIBA and provide
appropriate supportive care.
Because FEIBA is made from human plasma, it may carry a risk of
transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
The most frequently reported adverse reactions observed in
>5% of subjects in the prophylaxis trial were anemia, diarrhea,
hemarthrosis, hepatitis B surface antibody positive, nausea, and
vomiting.
The serious adverse reactions seen with FEIBA are
hypersensitivity reactions and thromboembolic events, including
stroke, pulmonary embolism and deep vein thrombosis.
Use of antifibrinolytics within approximately 6 to 12 hours
after the administration of FEIBA is not recommended.
Please see the FEIBA full Prescribing Information at:
http://www.baxter.com/downloads/healthcare_professionals/products/feiba_us_pi.pdf.
About OBIZUR
OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence]
is indicated for the treatment of bleeding episodes in adults with
acquired hemophilia A.
Limitations of Use:
• Safety and Efficacy of OBIZUR has not been established in
patients with baseline anti-porcine factor VIII inhibitor titer
greater than 20 BU.
• OBIZUR is not indicated for the treatment of congenital
hemophilia A or von Willebrand disease.
Detailed Important Risk Information
CONTRAINDICATIONS
OBIZUR is contraindicated in patients who have had
life-threatening hypersensitivity reactions to OBIZUR or its
components (including traces of hamster proteins).
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions can occur with OBIZUR. OBIZUR
contains trace amounts of hamster proteins. Early signs of allergic
reactions, which can progress to anaphylaxis, include angioedema,
chest-tightness, dyspnea, hypotension, wheezing, urticaria, and
pruritus. Immediately discontinue administration and initiate
appropriate treatment if allergic or anaphylactic-type reactions
occur.
Inhibitory Antibodies
Inhibitory antibodies to OBIZUR have occurred. Monitor patients
for the development of antibodies to OBIZUR by appropriate assays.
If the plasma factor VIII level fails to increase as expected, or
if bleeding is not controlled after OBIZUR administration, suspect
the presence of an anti-porcine factor VIII antibody. If such
inhibitory antibodies to anti-porcine factor VIII are suspected and
there is a lack of clinical response, consider other therapeutic
options.
Monitoring Laboratory Tests
• Perform one-stage clotting assay to confirm that adequate
factor VIII levels have been achieved and maintained
o Monitor factor VIII activity 30 minutes and
3 hours after initial dose
o Monitor factor VIII activity 30 minutes
after subsequent doses
• Monitor the development of inhibitory antibodies to OBIZUR.
Perform a Nijmegen Bethesda inhibitor assay if expected plasma
factor VIII activity levels are not attained or if bleeding is not
controlled with the expected dose of OBIZUR. Use Bethesda Units
(BU) to report inhibitor levels.
ADVERSE REACTIONS
Common adverse reactions observed in greater than 5% of subjects
in the clinical trial were development of inhibitors to porcine
factor VIII.
Please see full prescribing information for OBIZUR at:
www.baxter.com/downloads/healthcare_professionals/products/OBIZUR_PI.pdf.
About Baxter in Hemophilia
Baxter has more than 60 years experience in hemophilia and has
introduced a number of therapeutic firsts for hemophilia patients.
Baxter has the broadest portfolio of hemophilia treatments in the
industry and is able to meet individual therapy choices, providing
a range of options at each treatment stage. The company’s work
focuses on optimizing hemophilia care and improving the lives of
people worldwide living with bleeding disorders.
About Baxter BioScience
Baxter BioScience is a leading provider of therapeutic
treatments that save, sustain and improve the lives of people with
rare conditions, chronic diseases or limited treatment options.
Supported by advanced technical and manufacturing expertise, Baxter
BioScience has a broad pipeline built on a legacy of innovation in
bleeding disorders and immunology and is expanding to address
emerging opportunities in technology platforms such as gene therapy
and biosimilars. By mid-2015, Baxter expects to establish the
BioScience business as a separate, publicly traded,
innovation-oriented biopharmaceutical company.
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.
This release includes forward-looking statements concerning BAX
817, including expectations with regard to clinical data and
regulatory filings, as well as plans to separate Baxter's
biopharmaceutical and medical products businesses and related
research and development strategies. 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; additional clinical results; changes in
laws and regulations; issues with product quality, manufacturing or
supply, or patient safety issues; 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.
Baxter International Inc.Media ContactBrian Kyhos, (224)
948-5353media@baxter.comorInvestor ContactsMary Kay Ladone,
(224) 948-3371Clare Trachtman, (224) 948-3085
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