FDA approves Kogenate FS for Haemophilia A prophylaxis - Bayer HealthCare
The FDA has approved a new indication for Kogenate FS (antihemophilic factor VIII recombinant), from Bayer HealthCare, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with Haemophilia A. The approval is based on data from the SPINART study, published in the Journal of Thrombosis and Haemostasis, in which 84 patients ages 15 to 50 were randomized to either prophylaxis or on-demand treatment.
Safety and efficacy results from an analysis of the primary endpoint of bleeding frequency after a median follow-up period of 1.4 years provided the basis for the approval. The safety objectives were also met. Adverse events were consistent with the existing safety profile for Kogenate FS.
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