Fidanacogene elaparvovec
Beqvez (fidanacogene elaparvovec) is a gene pharmaceutical. Fidanacogene elaparvovec was first approved as Beqvez on 2024-04-25. It is used to treat hemophilia b in the USA.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Beqvez
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| beqvez | Biologic Licensing Application | 2024-05-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemophilia b | — | D002836 | D67 |
Agency Specific
FDA
EMA
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
6 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 | 1 | 2 | 2 | — | — | 5 |
| Hemophilia b | D002836 | — | D67 | 1 | 2 | 2 | — | — | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 1 | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fidanacogene elaparvovec |
| INN | fidanacogene elaparvovec |
| Description | Fidanacogene elaparvovec, sold under the brand name Beqvez, is a gene therapy delivered via adeno-associated virus used for the treatment of Hemophilia B (congenital Factor IX deficiency).
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3990034 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 413EU9081Y (ChemIDplus, GSRS) |
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Safety
Black-box Warning
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Adverse Events
0 adverse events reported
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