Novo Nordisk, inc issued the following announcement on May 21.
A new 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] achieved high factor IX activity for longer than those treated with rFIXFc [Coagulation Factor IX (Recombinant), Fc Fusion Protein]. Factor IX activity observed with Rebinyn® was 4.39 times greater than rFIXFc and increased over time, providing six-times greater activity at seven days than rFIXFc at the same dose. These pharmacokinetic findings from the paradigm™7 trial were presented today at the WFH 2018 World Congress in Glasgow, UK.1
"Until now, there has been no direct pharmacokinetic comparison of these two extended half-life therapies," said Mindy Simpson, M.D., a hematologist/oncologist at Rush University Medical Center in Chicago and an investigator in the paradigm™7 trial comparing Rebinyn® and rFIXFc. "The study results provide clinicians a better understanding of the pharmacokinetic differences between these hemophilia B treatments."
Thirty minutes after administration, factor IX levels were twice as high in adults treated with Rebinyn® versus those who received rFIXFc. Rebinyn® also prolonged factor IX activity in the body much longer than rFIXFc, achieving an average half-life of 103.2 hours vs. 84.9 hours, respectively.1
"Rebinyn® is a prime example of our deep, ongoing commitment to the rare disease community," said 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."
Original source can be found here.
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