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 |
| Novoeight | Antihemophilic Factor (Recombinant) | Novo Nordisk | N-125466 RX | 2013-10-15 | 6 products |
| Nuwiq | Antihemophilic Factor (Recombinant) | Octapharma | A-125555 RX | 2015-09-04 | 8 products |
| Nuwiq | Antihemophilic Factor (Recombinant) | Octapharma | N-125555 RX | 2015-09-04 | 8 products |
| Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | Takeda | A-103375 RX | 1992-12-10 | 5 products |
| Bioclate (Armour), Recombinate | Antihemophilic Factor (Recombinant) | Takeda | N-103375 RX | 1992-12-10 | 5 products |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| altuviiio | Biologic Licensing Application | 2026-02-23 |
| recombinate | Export only | 2010-05-26 |
| xyntha | Biologic Licensing Application | 2011-01-13 |
Indications
FDA
EMA
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Agency Specific
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Clinical
Clinical Trials
422 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 | 49 | 43 | 121 | 53 | 128 | 368 |
| Hemophilia b | D002836 | — | D67 | 3 | 3 | 14 | 3 | 12 | 33 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 5 | 1 | 13 | 3 | 12 | 33 |
| Hemostatic disorders | D020141 | — | — | 4 | 2 | 9 | 3 | 9 | 26 |
| Von willebrand diseases | D014842 | EFO_0003910 | D68.0 | 1 | 3 | 14 | 3 | 3 | 23 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 6 | 3 | 8 | 17 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | 4 | 2 | 5 | 12 |
| Coagulation protein disorders | D020147 | — | — | 1 | — | 5 | 1 | 4 | 11 |
| Inherited blood coagulation disorders | D025861 | — | — | — | — | 3 | 1 | 5 | 9 |
| Recurrence | D012008 | — | — | — | — | — | 1 | 2 | 3 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | 4 | — | 3 | 7 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | 3 | — | 3 | 6 |
| Type 3 von willebrand disease | D056729 | Orphanet_166096 | D68.03 | 1 | — | 1 | — | 2 | 4 |
| Hemarthrosis | D006395 | EFO_1001344 | M25.0 | — | 1 | 1 | — | 2 | 3 |
| X-linked genetic diseases | D040181 | — | — | — | — | 1 | — | 1 | 2 |
| Bone diseases | D001847 | — | M89.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | 1 | — | — | — | 5 |
| Genetic therapy | D015316 | — | — | 1 | 1 | — | — | 1 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | 1 | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | — | — | — | 1 |
| Hemostasis | D006487 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | 1 | — | — | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
| Factor vii deficiency | D005168 | — | D68.2 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 3 | 3 |
| Sclerosis | D012598 | — | — | — | — | — | — | 3 | 3 |
| Thrombosis | D013927 | — | — | — | — | — | — | 3 | 3 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 2 | 2 |
| Postpartum hemorrhage | D006473 | — | O72 | — | — | — | — | 2 | 2 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 2 | 2 |
| Pregnancy complications | D011248 | — | — | — | — | — | — | 2 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Seroma | D049291 | — | — | — | — | — | — | 1 | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | — | — | 1 | 1 |
Show 42 more
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) |
Target
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Variants
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Advate – Takeda
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Refacto – Pfizer
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Novoeight – Novo Nordisk
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Altuviiio – Sanofi
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Safety
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Adverse Events
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15,405 adverse events reported
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