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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Roctavian
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
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 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | 1 | — | — | — | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 1 | 1 | — | — | — | 1 |
| Genetic therapy | D015316 | — | — | 1 | 1 | — | — | — | 1 |
| Hemostatic disorders | D020141 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Roctavian – BioMarin Pharmaceutical
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 305 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use