| Definition | Turoctocog alfa pegol is a pegylated version of [turoctocog alfa]. Novo Nordisk's brand name Esperoct (turoctocog alfa pegol, N8-GP) was approved by the US FDA on February 19, 2019.
Fundamentally, the N8-GP moiety is identical to [turoctocog alfa], a recombinant human clotting factor VIII (rFVIII) with a truncated B-domain made from the sequence coding for 10 amino acids from the N-terminus and 11 amino acids from the C-terminus of the naturally occurring B-domain [F3685]. Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human or animal-derived materials [F3685]. During secretion, some rFVIII molecules are cleaved at the C-terminal of the heavy chain (HC) at amino acid 720, and a monoclonal antibody binding C-terminal to this position is used in the purification process allowing isolation of the intact rFVIII [A31504]. It was developed by Novo Nordisk and approved by the US FDA on October 16, 2013 [L1104].
The essential difference between turoctocog alfa and N8-GP, however, is the specific attachment of a 40-kDa polyethylene glycol (PEG) group to a specific _O_-glycan in the truncated B-domain of the general turoctocog alfa rFVIII structure [A31506, A32069]. This modification to the general turoctocog alfa rFVIII structure makes N8-GP an extended half-life factor VIII molecule for factor VIII replacement therapy in patients with factor VIII deficiency, or hemophilia A [F3649]. As such, turoctocog alfa pegol is a valuable expansion to the drug therapies available for treating hemophilia A as it ultimately provides a less burdensome and more convenient dosing regimen for patients that is less frequent than that for turoctocog alfa. |
|---|
