October 13, 2008
Bayer Wins FDA Approval for Hemophilia Drug
Bayer HealthCare has announced that the FDA has approved routine prophylaxis with Kogenate FS Antihemophilic Factor 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, the company said.
The FDA approval of Kogenate FS for routine prophylaxis in children without pre-existing joint damage is based on the clinical data from a multicenter trial in the US that included 65 boys with severe hemophilia A less than 30 months of age at study entry.
This 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 US label.
Paul Bedard, vice president and general manager of hematology business unit, Bayer HealthCare, said: "Today's announcement is a milestone in Bayer HealthCare's continuing commitment to advancing the science and treatment for the hemophilia community. 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."