Page 31 - HFA Dateline 2022 Special Edition

FDA INDICATIONS/
THERAPY NAME MANUFACTURER THERAPY TYPE SPECIFIC THERAPY TYPE HALF-LIFE APPROVAL TARGET NOTES
Advate Takeda Recombinant clotting factor Antihemophilic Factor Adults(>16 years)= 12.0 ± 4.2 hrs ; 12 to 2003 Factor VIII
(Recombinant) <16 yrs= 12.0 ± 2.9; 5 to <12 yrs=11.2 ± 3.5
hrs; 2 to <5 yrs=9.5 ± 1.8 hrs; 1 month to <2
yrs=8.7 ± 1.4 hrs
Adynovate Takeda Recombinant clotting factor Antihemophilic Factor 18 years= 14.69 ± 3.79 hrs; 12 to <18 years= 2015 Factor VIII
(Recombinant), PEGylated 13.43 ± 4.05 hrs; 6 to <12 years= 12.4 ±
1.67 hrs; <6 years= 11.8 ± 2.43 hrs. Overall
1.3-1.5 half-life extension compared to
ADVATE

Afstyla CSL Behring Recombinant clotting factor After single dose of 50 IU/kg: 2016 Factor VIII
Adults (≥18 years): 14.2 hours (mean);
Adolescents (≥12 to <18 years): 14.3 hours
(mean); Children: (0 to <6 yrs): 10.4
hours (mean); (≥6 to <12 years): 10.2
hours (mean)

Alphanate Grifols Plasma-derived clotting factor 17.9 1978 Factor VIII;
VWD

Cyklokapron Pfizer Non-factor product Antifibrinolytic Agent 2 hours 1 1986 Factor VIII; 1-terminal elimination phase 2-indicated in
(tranexamic Factor IX patients with hemophilia for short-term use
acid injection) (two to eight days) to reduce or prevent
hemorrhage and reduce the need for
replacement therapy during and following
tooth extraction

DDAVP Ferring Pharmaceuticals Non-factor product Intravenous Injection-Factor 1978 Factor VIII;
(Desmopressin) catalyst/factor booster/factor VWD
precipitator
Desmopressin Dr. Reddy's Laboratories Non-factor product Intravenous Injection-Factor 2020 Factor VIII;
Acetate Injection catalyst/factor booster/factor VWD
USP (desmopressin precipitator
acetate)

Eloctate Sanofi Recombinant clotting factor Antihemophilic Factor Adults - 19.7 hours (17.4, 22.0) Pediatric - 2014 Factor VIII PK parameters were determined after a single
(Recombinant), Fc Fusion Protein 12 to 17 years: 16.4 hours (14.1, 18.6) 6 to 11 50 IU/KG dose
years: 14.9 hours
(12.0, 17.8) 1 to 5 years: 12.7 hours (11.2, 14.1)

ESPEROCT Novo Nordisk Recombinant clotting factor Glycopegylated Single-dose 50 IU/kg Adults: 21.7 hours 2019 Factor VIII
Adolescents (12 to <18 years old):
17.4 hours Children (6 to <12 years old): 13.8
hours Children (1 to <6 years old): 14.7 hours

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