Helixate® FS Factor VIII Efficacy

In clinical studies involving surgeries for previously treated and untreated hemophilia
patients, 100% of patient responses with Helixate® FS were rated as excellent/good.
In untreated or minimally treated patients, only 15% of patients developed an inhibitor 1
in patients who had previously received factor therapy, none of the patients developed
a new inhibitor.2
In a study of 61 infants and young children with hemophilia who had not previously
received factor therapy or who had been minimally treated1:
- Helixate® FS effectively treated the majority of bleeding episodes with
only 1 or 2 infusions
- The incidence of inhibitor development was only 15%
- Helixate® FS was used in 27 surgical procedures with minimal blood loss
in all cases; no procedure required transfusion of blood or blood derivatives
- An independent analysis of the study population supports the inhibitor formation
data
- Patients had a risk mutation profile typical of patients with severe hemophilia
A and comparable to the profile of previously untreated patients in other rFVIII
studies3
In a study of 71 patients who had previously received factor therapy2:
- 94% of 2,585 bleeding episodes were treated successfully with 1 or 2 infusions of
Helixate® FS
- The incidence of new inhibitor development in these patients was 0%
- Adverse events (ie, side effects) were reported in less than 1% of infusions, with
no patients discontinuing therapy because of adverse effects
Next: Proven Safety >>
1. Kreuz W, Gill JC, Rothschild C, et al, and the International Kogenate-FS Study
Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously
untreated or minimally treated young children with severe haemophilia A; results
of an international clinical investigation. Thromb Haemost. 2005;93:457-467.
2. Abshire TC, Brackmann H-H, Scharrer I, et al, and the International Kogenate-FS
Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is
safe and efficacious for treatment of hemophilia A in home therapy.
3. Oldenburg, Johannes; Thrombosis and Haemostasis; May 2006.