Bayer HealthCare announced that the FDA has approved a new indication for Kogenate FS (antihemophilic factor VIII [recombinant]) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
The FDA approval is based on data from the SPINART study, in which patients (n=84) ages 15–50 were randomized to either prophylaxis (25 IU/kg three times weekly) or on-demand treatment. Patients who received prophylaxis experienced significantly fewer bleeds (P<0.0001) vs. patients treated on-demand regardless of baseline subgroups studied.
The ratio of the mean bleeding frequency was 15.2 (95% CI: 8.5, 27.2; P<0.0001) for on-demand vs. prophylaxis. Also, the mean annualized bleed rates were 37 in the on-demand group vs. 2 in the prophylaxis group. The median annualized bleed rate in the on-demand group was 33 vs. 0 in the prophylaxis group.
Kogenate FS is already indicated for the control and prevention of bleeding episodes in adults and children (0–16 years) with hemophilia A; peri-operative management in adults and children with hemophilia A; and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
For more information call (888) 842-2937 or visit KogenateFS.com.