Bioclate (armour), recombinate, Helixate nexgen(octocog alfa)
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
FDA
EMA
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Agency Specific
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
401 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 | 39 | 115 | 55 | 120 | 354 |
| Hemophilia b | D002836 | — | D67 | 3 | 3 | 13 | 2 | 12 | 31 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 5 | 1 | 7 | 3 | 9 | 24 |
| Hemostatic disorders | D020141 | — | — | 5 | 1 | 7 | 3 | 9 | 24 |
| Von willebrand diseases | D014842 | EFO_0003910 | D68.0 | 1 | 3 | 13 | 3 | 3 | 22 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 4 | 4 | 4 | 12 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | 1 | 2 | 2 | 6 |
| Inherited blood coagulation disorders | D025861 | — | — | — | — | — | 1 | 3 | 4 |
| Recurrence | D012008 | — | — | — | — | — | 1 | 2 | 3 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | 2 | — | 2 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | 1 | — | 1 | 2 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | 1 | — | 1 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | 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 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | 3 | 4 |
| Genetic therapy | D015316 | — | — | 1 | 1 | — | — | 1 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 3 von willebrand disease | D056729 | Orphanet_166096 | D68.03 | 1 | — | — | — | 2 | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 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 |
| Joint diseases | D007592 | — | M12.9 | — | — | — | — | 2 | 2 |
| Coagulation protein disorders | D020147 | — | — | — | — | — | — | 2 | 2 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 2 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Seroma | D049291 | — | — | — | — | — | — | 1 | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | — | — | 1 | 1 |
| Replacement arthroplasty | D019643 | — | — | — | — | — | — | 1 | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Hemolysis | D006461 | — | — | — | — | — | — | 1 | 1 |
Show 38 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Octocog alfa |
| 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.
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| 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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Advate – Takeda
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Additional graphs summarizing 1,004 documents
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Safety
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Adverse Events
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11,814 adverse events reported
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