Luxturna(voretigene neparvovec)
Luxturna (voretigene neparvovec) is a gene pharmaceutical. Voretigene neparvovec was first approved as Luxturna on 2017-12-19. It has been approved in Europe to treat leber congenital amaurosis and retinitis pigmentosa.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Luxturna
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)
Voretigene neparvovec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Luxturna | Voretigene Neparvovec | Spark Therapeutics | A-125610 RX | 2017-12-19 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| luxturna | Biologic Licensing Application | 2024-04-12 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
voretigene neparvovec, Luxturna, Spark Therapeutics, Inc. | |||
| 2024-12-19 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3398 | Injection, voretigene neparvovec-rzyl, 1 billion vector genomes |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Retinal dystrophies | D058499 | HP_0000556 | — | — | — | 2 | — | 2 | 4 |
| Blindness | D001766 | HP_0000618 | H53.12 | 2 | 1 | 1 | — | — | 3 |
| Leber congenital amaurosis | D057130 | Orphanet_65 | H35.5 | 2 | 1 | 1 | — | — | 3 |
Indications Phases 2
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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 | Voretigene neparvovec |
| INN | voretigene neparvovec |
| Description | Voretigene neparvovec, sold under the brand name Luxturna, is a gene therapy medication for the treatment of Leber congenital amaurosis.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707275 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13932 |
| UNII ID | 2SPI046IKD (ChemIDplus, GSRS) |
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Additional graphs summarizing 1,929 documents
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Safety
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172 adverse events reported
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