EU-Approval for Continuous Infusion of KOGENATE(R) Bayer
- Category: Proteins and Peptides
- Published on Friday, 09 February 2007 02:00
- Hits: 2573
LEVERKUSEN, Germany | Feb 8, 2007 | KOGENATE® Bayer, a recombinant Factor VIII product for the treatment of hemophilia A, received EU approval for continuous infusion in hemophilia A patients undergoing major surgery. Bayer HealthCare, manufacturer of the KOGENATE® product line, is the first to be granted the continuous infusion indication by the European Commission for all EU countries.
“The EU Commission approval of continuous infusion of KOGENATE® Bayer is a major advancement in hemophilia care, as continuous infusion as a practice is associated with excellent patient outcomes and provides surgeons with increased confidence in treating these patients,” said Dr. Lemm, MD PhD, Director of Global Clinical Development Kogenate, Bayer HealthCare.
For surgeons operating on patients with hemophilia A, continuous infusion with KOGENATE® Bayer may also be more convenient than bolus injection. Blood sampling can be conducted at any time using continuous infusion, and in general, factor levels remain more predictable, allowing for straightforward, consistent monitoring.
“Surgery in patients with hemophilia is challenging because hemostatic factor levels must be regularly monitored and controlled to reduce bleeding,” said Georg Lemm. „In contrast to bolus infusion, continuous infusion of Factor VIII can lower the risk that factor levels will drop below the therapeutic hemostatic level, resulting in less bleeding complications.“
Research confirms that excellent hemostatic efficacy can be achieved with continuous infusion of KOGENATE® Bayer. A recent clinical study rated hemostasis with continuous infusion of KOGENATE® Bayer to be ‘excellent’ (87%) or ‘good’ (13%) in all patients. Bleeding and blood loss during surgery were within expected ranges. Treatment was well tolerated without any unexpected safety concerns, and there were no drug-related treatment-emergent adverse events. Additionally, no patient developed de novo inhibitor antibodies to KOGENATE® Bayer.
About KOGENATE® Bayer
KOGENATE® Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) is a hemophilia A treatment offering patients proven control for bleeding episodes in a simple-to-use delivery system. The safety, efficacy and overall reliability of the Kogenate® line of products are based on more than 18 years of clinical experience and over 6 billion IUs infused. Clinical data shows that KOGENATE® Bayer (rFVIII) provided excellent hemostatic control, was well tolerated, and has a proven safety profile in patients with hemophilia A. For important safety and use information, please see the attached full prescribing information. KOGENATE® Bayer is manufactured at Bayer’s state-of-the-art biotechnology facility in Berkeley, California.
Approximately 400,000 people around the world have hemophilia. Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division, Bayer Schering Pharma AG, comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology.
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