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Pfizer announces positive top-line results from phase 3 study of NONACOG ALFA (BeneFIX) once-weekly Prophylaxis for Hemophilia B


Wednesday, 16 Jul 2014 07:00am EDT 

Pfizer Inc:Announces positive results of phase 3 study comparing prophylaxis regimen of BeneFIX(reg)Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B.Top-line results of study showed that primary study endpoint was met and Hemophilia B patients taking once-weekly BeneFIX (100 IU/Kg) showed statistically reduction in annualized bleeding rate (ABR) (P < 0.0001) relative to on-demand treatment with BeneFIX.In study, median ABR value, commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for prophylaxis regimen, compared to 33.6 for on-demand regimen, representing 94 pct decrease in bleeding rates.Mean ABR value was 3.6 for prophylaxis period, compared to 32.9 for on-demand treatment, which represents reduction of 89 pct (P < 0.0001).Study results showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX.Median spontaneous ABR value was 1.0 for prophylaxis regimen, compared to 22.4 for on-demand regimen, and median traumatic ABR value was 1.0 for prophylaxis period, compared to 4.1 for on-demand treatment.In addition to meeting primary endpoint, secondary study endpoints showed that none of 1,254 prophylaxis infusions administered during study were associated with less than expected therapeutic effect (LETE) occurrence. 

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20 Nov 2014