G. Sottilotta
Abstract
What is the rationale for a new concentrate of a Factor IX (FIX) Extended Half Life? The reduction of the Annual Bleeding Ratio (ABR) and the prevention of further hemarthrosis in the target joints through weekly infusions. Other objectives are: the improvement of the joint status and the quality of life thanks to the possibility of reducing the frequency of prophylactic infusions, and the reduction of the risk of inhibitors. Nonacog beta pegol N9-GP (Refixia, Novonordisk) is an increased half-life recombinant FIX (rFIX) that meets all these needs. Refixia is produced in Chinese hamster ovary (CHO) cells by a serum-free manufacturing process.
What are its characteristics? Refixia is a purified rFIX) with a 40 kilo Dalton (kDa) polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide.
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