Table 1.
Standard half-life factor VIII products.
| Product | Approval year | FVIII protein | Cell line | Mean half-life, hours | Comparator mean half-life (product) | Prophylaxis regimen |
|---|---|---|---|---|---|---|
| Kogenate® FS26 | 1993 | Full length | BHK | 13.7 | – | 25 IU/kg 3× per week |
| Helixate® FS27 | 1993 | Full length | BHK | 13.7 | – | 25 IU/kg 3× per week |
| Advate®28 | 2003 | Full length | CHO | 12.0 | – | 20–40 IU/kg every other day or every 3 days to maintain trough >1% |
| Moroctocog alfa (Xyntha®)29 | 2008 | B-domain deleted | CHO | 11.2 | 13.3 (Advate®) |
30 IU/kg 3× per week |
| Turoctocog alfa (NovoEight®)19–21 | 2013 | B-domain truncated | CHO | 10.8 | 11 (Advate®) |
20–50 IU/kg 3× per week or 20–40 IU/kg every other day |
| Simoctocog alfa (Nuwiq®)32,33,35 | 2015 | Full length | HEK | 17.1* | Bioequivalent (Kogenate® FS) | 30–40 IU/kg every other day |
| Octocog alfa (Kovaltry®)22–25 | 2016 | Full length | BHK | 13.4 | 12.2 (Kogenate® FS) |
20–40 IU/kg 2–3× per week |
| rVIII-single chain (Afstyla®)37–39 | 2016 | B-domain and four amino-acids of a3 domain deleted | CHO | 14.5 | 13.3 (Advate®) |
20–50 IU/kg 2–3× per week |
BHK: baby hamster kidney; CHO: Chinese hamster ovary; FS: sucrose-formulated; HEK: human embryonic kidney; IU: international unit. *Median, lower/upper quartile: 13.7, 12.0/17.5.