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Analysis of Four Large Post-Marketing Surveillance Studies Describe Clinical Effects of Sucrose-Formulated Recombinant Factor VIII
Date:7/13/2009

BOSTON, July 13 /PRNewswire/ -- New data pooled from four large, "real world" post-marketing surveillance studies showed that sucrose-formulated recombinant factor VIII (rFVIII-FS) reduced bleeding and provided data regarding adverse events in more than 950 patients with mild-to-severe hemophilia A. Additionally, rates of inhibitor formation were reported in both previously treated and previously untreated patients. The data were presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH).(1)(2)

In this analysis, the investigators judged rFVIII-FS hemostasis to be "good" or "very good" in 98.9 percent of patients. Serious adverse drug reactions were seen in 1.1 percent of patients and new (de novo) inhibitors were observed in 0.8 percent of patients.

"In a 'real world' setting, these data reflect some of the extensive global clinical experience with rFVIII-FS," said Georg Lemm, M.D., Ph.D., vice president, Global Clinical Development, and head, Hematology Group, Bayer Schering Pharma. "It is particularly noteworthy that a low rate of inhibitor formation was observed in this analysis of data pooled from post-marketing surveillance studies. Inhibitor formation is a significant challenge for both clinicians and their patients, and its treatment is costly and requires significant time to overcome."

Open label study investigating the efficacy of prophylactic versus on-demand rFVIII-FS treatment

In another presentation, (3) data from an open label clinical study that enrolled 20 adult men with severe hemophilia A (with and without target joints) demonstrated that patients who were changed from on-demand to prophylactic (preventive) infusions of rFVIII-FS had significantly reduced median joint bleeds per 6-month treatment period (zero events versus 15.0 events, respectively; P<0.001) and improved median total Gilbert Scores (18 versus 25, respec
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SOURCE Bayer HealthCare
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