Bioclate (armour), recombinate, Helixate nexgen(antihemophilic factor human recombinant)
Advate, Kovaltry (octocog alfa) is a protein pharmaceutical. Octocog alfa was first approved as Kogenate bayer on 2000-08-04. It has been approved in Europe to treat hemophilia a.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bioclate (armour), recombinate, Novoeight, Nuwiq (discontinued: Helixate fs, kogenate, kogenate fs, Refacto)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Antihemophilic factor (recombinant)
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Novoeight | Antihemophilic Factor (Recombinant) | Novo Nordisk | A-125466 RX | 2013-10-15 | 6 products |
| Nuwiq | Antihemophilic Factor (Recombinant) | Octapharma | A-125555 RX | 2015-09-04 | 8 products |
| Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | Takeda | A-103375 RX | 1992-12-10 | 5 products |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| altuviiio | Biologic Licensing Application | 2025-03-11 |
| recombinate | Export only | 2010-05-26 |
| xyntha | Biologic Licensing Application | 2011-01-13 |
Indications
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EMA
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Agency Specific
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HCPCS
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Clinical
Clinical Trials
414 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia a | D006467 | EFO_0007267 | D66 | 8 | 3 | 8 | 7 | 26 | 50 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | 1 | 3 | 5 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | 1 | 1 | 2 |
| Hemostatic disorders | D020141 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | 1 | — | 2 | 3 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 2 | 2 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Antihemophilic factor human recombinant |
| INN | octocog alfa |
| Description | Factor VIII is a medication used to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII. Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.
|
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108455 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | P89DR4NY54 (ChemIDplus, GSRS) |
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Altuviiio – Sanofi
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Novoeight – Novo Nordisk
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Advate – Takeda
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Refacto – Pfizer
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Tabular view
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Trends
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Safety
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Adverse Events
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14,523 adverse events reported
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