Kogenate FS approved for pediatric hemophilia A prophylaxis
Date Posted: October 13, 2008
Bayer's Kogenate FS (recombinant antihemophilic
Factor VIII) has been approved for the prophylaxis of hemophilia A in children 0-16 years of age without pre-existing joint damage.
This approval was based on a clinical trial of 65 boys under 30 months old with severe hemophilia A that showed 93% of patients in the
prophylaxis group had normal joint function versus 55% in an episodic group. In addition, the prophylaxis group had an 81.5% reduction
in annual bleeding frequency and an 83% reduction in the risk of joint damage compared to the episodic group.
Kogenate FS is already
approved for the prevention and control of hemorrhagic episodes in Hemophilia A patients.