Turoctocog alfa pegol

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 . Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human or animal-derived materials . 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 . It was developed by Novo Nordisk and approved by the US FDA on October 16, 2013 . 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 . 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 . 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.

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 . Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human or animal-derived materials . 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 . It was developed by Novo Nordisk and approved by the US FDA on October 16, 2013 . 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 . 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 . 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.

Turoctocog alfa pegol is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. It is not indicated for the treatment of von Willebrand disease.

• Bleeding caused by Hemophilia A