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AboutPricing
Drug ReportsElivaldogene autotemcel
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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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
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
Skysonaelivaldogene autotemcelbluebird bioA-125755 RX2022-09-16
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
skysonaBiologic Licensing Application2025-08-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
adrenoleukodystrophyOrphanet_43D000326E71.52
Agency Specific
FDA
EMA
Expiration
Code
elivaldogene autotemcel, Skysona, Bluebird Bio Inc.
2034-09-16Reference product excl.
2029-09-16Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX21: Elivaldogene autotemcel
HCPCS
No data
Clinical
Clinical Trials
4 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
AdrenoleukodystrophyD000326Orphanet_43E71.52—12—24
Indications Phases 2
No data
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 nameElivaldogene autotemcel
INNelivaldogene autotemcel
Description
Elivaldogene autotemcel, sold under the brand name Skysona, is a gene therapy used to treat cerebral adrenoleukodystrophy (CALD). It was developed by Bluebird bio and was given breakthrough therapy designation by the U.S. Food and Drug Administration in May 2018.
Classification
Gene
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4594333
ChEBI ID—
PubChem CID—
DrugBankDB16746
UNII IDKUM75TD6SG (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Skysona – bluebird bio
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 122 documents
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Safety
Black-box Warning
Black-box warning for: Skysona
Adverse Events
Top Adverse Reactions
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9 adverse events reported
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