Bayer HealthCare says the US Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate 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 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).
"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. 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," said Dr Craig Kessler, Georgetown University Hospital and Chair, MASAC.
Dr. Kessler also said, "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."
This US 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.