FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children With...

Posted on: Friday, 10 October 2008, 12:00 CDT 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... [read full story]