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Phase 3 Results for Kogenate FS Presented at Hemophilia Meeting
Bayer Healthcare released preliminary data to the press on July 12.
A total of 84 subjects aged 12 to 50 years were randomly assigned to receive either prophylaxis with Kogenate FS (25 IU/kg three times per week) or on-demand treatment, with a planned follow-up period of 3 years.
After a median follow-up period of 1.7 years, significantly fewer bleeding events occurred per year with prophylaxis versus on-demand treatment (median, 0.0 vs. 27.9, respectively; P
Kogenate FS, antihemophilic factor (recombinant), is a recombinant factor V3 treatment indicated for the control and prevention of bleeding episodes and perioperative management in adults and children 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.
Bayer submitted an application to the FDA requesting an adult prophylaxis indication for Kogenate FS on June 21.
For more information, read the news article in the Sacramento Bee.