WHIPPANY N.J., Aug. 13, 2015 /PRNewswire/ -- Bayer HealthCare will present data on hemophilia A at the National Hemophilia Foundation’s (NHF) 67th Annual Meeting, which takes place August 13-15 in Dallas, TX. The data, which will be shared through poster presentations, showcase Bayer’s commitment to advancing hemophilia treatment and patient care.
“We are passionate about our ongoing research and efforts in developing treatments for patients with bleeding disorders,” said Dario Mirski, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “The data being presented at the NHF Annual Meeting demonstrate Bayer’s long-established partnership with and dedication to the hemophilia A community, and we are excited to share our findings.”
Notable studies, which will be shown as poster presentations during the poster session held Thursday, August 13, 2015 at 5:00 pm through Saturday, August 15, 2015 at 12:00pm include:
BAY 81-8973 Studies
Poster: BAY 81-8973: Pharmacokinetic Parameters in Adolescent, Adults, and Children with Severe Hemophilia A
Poster: BAY 81-8973: Safety Observations in Clinical Trials in Adults, Adolescents, and Children With Severe Hemophilia A
Poster: BAY 81-8973: The Effects of Routine Prophylaxis on Total, Joint, and Spontaneous Bleeding in Adolescents, Adults, and Children With Severe Hemophilia A
Bayer’s Sucrose-Formulated rFVIII Studies
Poster: SPINART 3-Year Analyses: Patient- and Joint-Level Changes in Colorado Adult Joint Assessment Scale and Magnetic Resonance Imaging Scores With Bayer’s Sucrose-Formulated Recombinant Factor VIII (rFVIII-FS) in Adolescents and Adults
Additional Studies and Results
Poster: Phase I Studies into BAY 94-9027 PEGylated B-Domain-Delted Recombinant rFVIII:
In Vitro Studies into BAY 1093884 Anti Tissue Factor Pathway Inhibitor Antibody:
Indications
Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for:
- Control and prevention of bleeding episodes in adults and children with hemophilia A.
- Surgical prophylaxis in adults and children with hemophilia A.
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
Kogenate FS is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Kogenate FS antihemophilic factor (recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.
Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.
Serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions (> or = 4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections.
For important risk and use information, please see the full prescribing information.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Media Contact:
Jane Ward
Tel. + 1 973 420 2876
E-Mail: jane.ward@bayer.com
Forward-Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer®, the Bayer Cross® and Kogenate® FS are registered trademarks of Bayer.
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SOURCE Bayer HealthCare
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