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Efficacy
Kogenate® and Kogenate® FS have a long history of efficacy across all patient groups.1-3
- Demonstrated excellent hemostatic response in previously untreated patients (PUPs) and minimally treated patients (MTPs).1, 2
- Demonstrated excellent hemostatic response in previously treated patients (PTPs).3
- In prospective controlled clinical trials, 89% of bleeds in PUPs and MTPs and 93% of the bleeds in PTPs were successfully treated with only 1 or 2 infusions.1-3
- Low incidence of inhibitor formation in PTPs and PUPS/MTPs.2-6
| Number of patients with severe hemophilia A |
61* |
71** |
| De novo inhibitor development |
16% |
None |
| Bleeds treated with 1 or 2 infusions |
89% |
93% |
* Long-term, prospective clinical trials conducted in 61 patients with severe hemophilia A (<2% FVIII activity), over 45 months in North America (NA: n=31) and Europe (EU: n=30). Total number of bleeding episodes in NA and EU combined were 1,173.
** Long-term, open-label, prospective clinical trials conducted in 71 patients with severe hemophilia A (<2% residual FVIII activity), over 18 months in North America (NA: n=38) and 24 months in Europe (EU: n=33). Total number of bleeding episodes in NA and EU combined were 5,673.
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1 Data on File, Bayer HealthCare, MRR 1603 based on combined history of Kogenate® and Kogenate® FS.
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2 Data on File, Bayer HealthCare, PH 31866.
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3 Abshire TC, Brackmann HH, Scharrer I, et al. Sucrose formulated recombinant human antihemophilic Factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost. 2000; 83(6):811-816.
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4 Ljung RCR. Annotation: Can haemophilic arthropathy be prevented? Br J Haematol 1998;101:215-9.
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5 Ljung RCR. Prophylactic infusion regimens iun the management of hemophiolia. Thromb Haemost 1999;82(2):525-30.
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6 Blanchette VS, McCready M, et al. A survey of factor prophylaxis in boys with haemophilia followed in North American haemophilia treatment centres. Haemophilia 2003;9(Suppl 1):19-26.
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