Pharmacokinetics, Safety, and Efficacy of Recombinant Factor VIII Fc Fusion Protein

Abstract

Prophylaxis for hemophilia A with conventional factor VIII (FVIII) products requires frequent intravenous dosing, which may reduce adherence. Recombinant factor VIII Fc fusion protein (rFVIIIFc) has a prolonged half-life compared with conventional rFVIII, and has demonstrated safety and efficacy for the prevention and treatment of bleeding episodes in phase 3 studies of patients with severe hemophilia A. Most subjects experienced reduced prophylactic dosing frequency with rFVIIIFc compared with prestudy FVIII; the median total weekly prophylactic consumption was comparable. No subjects developed inhibitors. These results suggest that prophylaxis with rFVIIIFc in patients with hemophilia A may allow less frequent prophylactic dosing while maintaining efficacy, with comparable prophylactic consumption.

Anti-Tumor Activity and Pharmacokinetics of AP25-Fc Fusion Protein

“…Fc-fusion proteins refer to the fusion of a functional protein with the Fc fragment of an antibody by the genetic engineering technology. This fusion strategy not only retains the biological activity of functional proteins, but also extends the half-life time, improves the stability, and facilitates the expression, purification and detection of the fusion proteins 9,10. More than a dozen Fc-fusion protein drugs have been commercialized, with annual sales of more than 10 billion US dollars.…”