Page 33 - HFA Dateline 2022 Special Edition

FDA INDICATIONS/
THERAPY NAME MANUFACTURER THERAPY TYPE SPECIFIC THERAPY TYPE HALF-LIFE APPROVAL TARGET NOTES

HEMLIBRA Genentech Bi-specific antibody Therapeutic bi-specific 26.9 +/- 9.1 days (mean +/- SD) 2017 Factor VIII; "2017 for inhibitors, 2018 for non-inhibitors
antibody Inhibitor Additional route of delivery information:
humanized, monoclonal, subcutaneous
injection"
Hemofil M Takeda Plasma-derived clotting factor Antihemophilic factor (human) 14.8 ± 3.0 hrs 1966 Factor VIII
method M, monoclonal purified

Humate-P CSL Behring Plasma-derived clotting factor 12.2 hours (mean) in Hemophilia A; 10-11 1986 Factor VIII;
hours (median) for VWD VWD

Jivi Bayer Recombinant clotting factor Antihemophilic factor (recombinant), 17.9 hours Via chromogenic assay 2018 Factor VIII Extended half-life
PEGylated-aucl

Koate Kedrion Biopharma Plasma-derived clotting factor 16.1 1974 Factor VIII

Kogenate FS Bayer Recombinant clotting factor Antihemophilic factor (recombinant) Adults: 13.74 hours Children: 10.7 hours 1993 Factor VIII

Kovaltry Bayer Recombinant clotting factor Antihemophilic factor (recombinant) 0 to <2 yrs : 9.6 hours 2 to <6 yrs: 12.2 2016 Factor VIII
hours 6 to <12 yrs: 12.0 hours 12 to 17
yrs: 14.4 hours >=18 yrs: 14.2 hours Via
chromogenic substrate assay

Novoeight Novo Nordisk Recombinant clotting factor Single-dose 50 IU/kg (adults/ 2013 Factor VIII
adolescents): One Stage Clotting
Assay-10.8 hours, Chromogenic Assay-12.0
hours. Single-dose 50 IU/kg (pediatrics):
One Stage Clotting Assay-0 to <6 years
old: 7.7 hours, 6 to <12 years old: 8.0 hours.
Chromogenic Assay-0 to <6 years old:
10.0 hours, 6 to <12 years old: 9.4 hours

NUWIQ Octapharma USA Recombinant clotting factor Antihemophilic recombinant 17.1 +/- 11.2hrs. (Adults); 13.1 +/- 2.6hrs. 2015 Factor VIII NUWIQ is a recombinant FVIII produced in
clotting factor (6-≤12 yrs.); 11.9 +/- 5.4hrs. (2-5 yrs.) human cells without chemical modication
or protein fusion. PUP data added to U.S.
label in 2020

Recombinate Takeda Recombinant clotting factor Antihemophilic factor (recombinant) 14.6 ± 4.9 hrs 1992 Factor VIII Half-Life 11.2 ± 2.5 vs Advate

Stimate Ferring Pharmaceuticals Non-factor product Nasal spray 3.3-3.5 hours 1994 Factor VIII; In February 2021, Ferring Pharmaceuticals
(Desmopressin VWD stated that it did not anticipate restarting
Nasal Spray) manufacturing and market delivery of
STIMATE before the second half of 2023,
®
contingent on FDA approval
Wilate Octapharma USA Plasma-derived clotting factor VWF: 15.8 hours; FVIII: 19.6 hours 2009 Factor VIII; Prophylaxis trial underway
VWD

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