Antihemophilic factor (recombinant), PEGylated
- Generic Name
- Antihemophilic factor (recombinant), PEGylated
- Brand Names
- Adynovate
- Drug Type
- Biotech
- CAS Number
- 1628187-15-4
Overview
Antihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product Adynovate . Antihemophilic Factor (Recombinant), PEGylated, is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of approximately 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa) . It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events , , . PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein. PEGylation decreases factor VIII clearance and allowing for an increased duration of drug circulation in the plasma .
Background
Antihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product Adynovate . Antihemophilic Factor (Recombinant), PEGylated, is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of approximately 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa) . It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events , , . PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein. PEGylation decreases factor VIII clearance and allowing for an increased duration of drug circulation in the plasma .
Indication
For the management of hemophilia A (congenital factor VIII deficiency) , . This medication is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency). It is also used for on-demand treatment and control of bleeding and routine prophylaxis of bleeding episodes. It is not indicated for the treatment of von Willebrand disease .
Associated Conditions
- Bleeding
- Perioperative Blood Loss
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2005/09/22 | N/A | Completed | Baxalta now part of Shire |
FDA Approved Products
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No FDA products found
No FDA products found for this drug
EMA Approved Products
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HSA Approved Products
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No HSA products found
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NMPA Approved Products
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No NMPA products found for this drug
PPB Approved Products
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TGA Approved Products
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No TGA products found
No TGA products found for this drug