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FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
Date:10/10/2008

ilia patients. Joint structural outcomes and functioning were measured at 6 years of age by radiography, magnetic resonance imaging (MRI) and physical exams.

"The value for prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available," said Val Bias, CEO, National Hemophilia Foundation. "Bayer HealthCare's pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients."

This U.S. FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.

"Today's announcement is a milestone in Bayer HealthCare's continuing commitment to advancing the science and treatment for the hemophilia community," said Paul Bedard, Vice President, General Manager, Hematology Business Unit, Bayer HealthCare. "From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients."

About Kogenate(R) FS

Kogenate(R) FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. The most serious adverse reactions are systemic hypersensitivity reactions i
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SOURCE Bayer HealthCare
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