Skysona(elivaldogene autotemcel)
Skysona (elivaldogene autotemcel) is a gene pharmaceutical. Elivaldogene autotemcel was first approved as Skysona on 2021-07-16. It is used to treat adrenoleukodystrophy in the USA. It has been approved in Europe to treat adrenoleukodystrophy.
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Commercial
Trade Name
FDA
EMA
Skysona
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)
Elivaldogene autotemcel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Skysona | elivaldogene autotemcel | bluebird bio | A-125755 RX | 2022-09-16 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| skysona | Biologic Licensing Application | 2022-09-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenoleukodystrophy | Orphanet_43 | D000326 | E71.52 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
elivaldogene autotemcel, Skysona, Bluebird Bio Inc. | |||
| 2034-09-16 | Reference product excl. | ||
| 2029-09-16 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
2 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 |
|---|---|---|---|---|---|---|---|---|---|
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | 1 | 1 | — | 1 | 2 |
Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ELIVALDOGENE AUTOTEMCEL |
| INN | elivaldogene autotemcel |
| Description | Elivaldogene autotemcel, sold under the brand name Skysona, is a gene therapy used to treat cerebral adrenoleukodystrophy (CALD). It is being developed by Bluebird bio.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594333 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16746 |
| UNII ID | KUM75TD6SG (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 31 documents
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Safety
Black-box Warning
Black-box warning for: Skysona
Adverse Events
Top Adverse Reactions
0 adverse events reported
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