Simoctocog alfa

Simoctocog alfa is a recombinant B-domain deleted (BDD) rFVIII produced in genetically modified human embryonic kidney (HEK) 293F cells. The harvested product is concentrated and purified by a series of chromatography steps. It is an antihemorrhagic agent used as a replacement therapy in individuals with Haemophilia A who lack the factor VIII in the intrinsic pathway of blood coagulation system. As patients with haemophilia A are predisposed to episodes of recurrent bleeding , simoctocog alfa can be administered for the treatment or prevention of bleeding such as prior to surgical procedures.

Simoctocog alfa is a glycoprotein consisting of 1440 amino acids with an approximate molecular mass of 170 kDa, comprising the FVIII domains A1-A2 + A3-C1-C2 whereas the B-domain, present in the full-length plasma-derived FVIII, has been deleted and replaced by a 16 amino acid linker. Simoctocog alfa is a fourth-generation BDD FVIII product made in the human embryonic kidney (HEK) cell line. Full human post-translational modifications via elimination of potentially immunogenic glycosylation patterns found in non-human cell lines led to decreased immunogenicity and longer half-life .

Simoctocog alfa is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII) indicated in adults and children with Hemophilia A for the 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.