Results from a recent head-to-head pharmacokinetic study show Rebinyn is more effective than rFIXFc in adults with hemophilia B.
Results from a recent head-to-head pharmacokinetic study showed that adults with hemophilia B who received a single dose (50 IU/kg) of Rebinyn [Coagulation Factor IX (Recombinant), GlycoPEGylated] obtained high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Findings from the paradigm™7 trial comparing Rebinyn® and rFIXFc were presented at the WFH 2018 World Congress in Glasgow, UK.
Factor IX activity was shown to be 4.39 times greater in patients treated with Rebinyn versus rFIXFc and exhibited an increase over time. Its activity was 6 times greater at 7 days than rFIXFc at the same dosage.
In a recent statement, Mindy Simpson, MD, a hematologist/oncologist at Rush University Medical Center in Chicago and an investigator in the study stated: "Until now, there has been no direct pharmacokinetic comparison of these two extended half-life therapies. The study results provide clinicians a better understanding of the pharmacokinetic differences between these hemophilia B treatments."
Rebinyn is an extended half-life factor IX molecule intended for the on-demand treatment of bleeding and perioperative management in patients with hemophilia B, an inherited and chronic bleeding disorder that commonly occurs in males. The condition is characterized by congenital factor IX deficiency, causing missing or reduced levels of clotting factor IX, which is a primary protein necessary for full-functioning blood clotting.
Paradigm 7 was a multicenter, open-label, randomized, crossover, pharmacokinetic trial conducted in previously treated adult males with congenital hemophilia B (factor IX activity ≤2%). The trial was held in 3 countries, including the United States, Germany, and Switzerland. Single injections (50 IU/kg) of Rebinyn and rFIXFc were administered to subjects with ≥21 days between doses. Dose-normalized area under the factor IX activity-time curve was the primary endpoint.
Additionally, factor IX levels were twice as high in adults treated with Rebinyn versus those who received rFIXFc 30 minutes post administration. An average half-life of 103.2 hours vs. 84.9 hours, respectively, was also achieved since factor IX activity was also prolonged in the body much longer than rFIXFc.
"Rebinyn is a prime example of our deep, ongoing commitment to the rare disease community," added Pia D' Urbano, Corporate Vice President, Biopharmaceuticals, Novo Nordisk Inc. "We are proud to offer people living with hemophilia B an extended half-life treatment that can help them reach and maintain high factor IX levels for a long period of time."
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