Roctavian(valoctocogene roxaparvovec)
Roctavian (valoctocogene roxaparvovec) is a gene pharmaceutical. Valoctocogene roxaparvovec was first approved as Roctavian on 2022-08-24. It is used to treat hemophilia a in the USA.
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Commercial
Therapeutic Areas
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Roctavian
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)
Valoctocogene roxaparvovec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Roctavian | valoctocogene roxaparvovec-rvox | BioMarin Pharmaceutical | A-125720 RX | 2023-06-29 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| roctavian | Biologic Licensing Application | 2024-03-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemophilia a | EFO_0007267 | D006467 | D66 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
valoctocogene roxaparvovec, Roctavian, Biomarin Pharmaceutical Inc. | |||
| 2030-06-29 | Orphan excl. | ||
Patent Expiration
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Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia a | D006467 | EFO_0007267 | D66 | 3 | 3 | 4 | — | 1 | 8 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | 1 | — | — | 2 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 1 | 1 | 1 | — | — | 2 |
| Hemostatic disorders | D020141 | — | — | 1 | 1 | 1 | — | — | 2 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | 1 | — | — | 1 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | 1 | — | — | 1 |
| Inherited blood coagulation disorders | D025861 | — | — | — | — | 1 | — | — | 1 |
| Coagulation protein disorders | D020147 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Genetic therapy | D015316 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Valoctocogene roxaparvovec |
| INN | valoctocogene roxaparvovec |
| Description | Valoctocogene roxaparvovec, sold under the brand name Roctavian, is a gene therapy used for the treatment of hemophilia A. It was developed by BioMarin Pharmaceutical. Valoctocogene roxaparvovec is made of a virus (AAV5) that has been modified to contain the gene for factor VIII, which is lacking in people with hemophilia A. It is an adeno-associated virus vector-based gene therapy. It is given by intravenous infusion.
|
| Classification | Gene |
| Drug class | Antihemorrhagics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1819334-78-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297579 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15561 |
| UNII ID | 681K1JDI8M (ChemIDplus, GSRS) |
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Roctavian – BioMarin Pharmaceutical
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Safety
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20 adverse events reported
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