FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with He...( Pivotal Data Show Prophylaxis Tre...),Health

Pivotal Data Show Prophylaxis Treatment with Kogenate FS Reduces the Risk of Joint Damage and Frequent Bleeds in Children with No Pre-Existing Joint Damage

BERKELEY, Calif., Oct. 10 /PRNewswire/ -- Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage. This important approval provides these patients with the only factor VIII treatment that the FDA has determined safe and effective for routine prophylaxis -- a treatment regimen recommended by the National Hemophilia Foundation's Medical and Scientific Advisory Council (MASAC).(1)

"The FDA approval of Kogenate FS as the first factor VIII treatment product in the U.S. to be used to replenish factor VIII levels in a prophylactic manner marks a significant milestone in the care of patients, especially young children, with hemophilia A," said Craig Kessler, M.D., Georgetown University Hospital and Chair, MASAC. "The results from the pivotal clinical study confirmed that the administration of Kogenate FS to prevent bleeding into the joints was more beneficial to joint health and function than 'on-demand' treatment of acute episodes of joint bleeds."

Dr. Kessler added, "The data justify the consideration of prophylaxis treatment for children with severe and moderate severity hemophilia A, uncomplicated by pre-existing joint damage, to be the medical standard of care. The FDA's recognition that Kogenate FS is an effective prophylactic FVIII replacement product has 'jump started' the standard of hemophilia care in the United States so that it is now on par with other developed countries, especially those in Western and Northern Europe."

The FDA approval of Kogenate(R) FS for routine prophylaxis in children without
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