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Drug ReportsPegunigalsidase alfa
Elfabrio(pegunigalsidase alfa)
Elfabrio (pegunigalsidase alfa) is an enzyme pharmaceutical. Pegunigalsidase alfa was first approved as Elfabrio on 2023-05-04. It is used to treat fabry disease in the USA. It has been approved in Europe to treat fabry disease.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Elfabrio
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)
Pegunigalsidase alfa
Tradename
Proper name
Company
Number
Date
Products
Elfabriopegunigalsidase alfa-iwxjChiesi FarmaceuticiN-761161 RX2023-05-09
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
elfabrioBiologic Licensing Application2024-07-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
fabry diseaseOrphanet_324D000795E75.21
Agency Specific
FDA
EMA
No data
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
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB20: Pegunigalsidase alfa
HCPCS
No data
Clinical
Clinical Trials
14 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
Fabry diseaseD000795Orphanet_324E75.21248—414
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 namePegunigalsidase alfa
INNpegunigalsidase alfa
Description
Pegunigalsidase alfa, sold under the brand name Elfabrio, is an enzyme replacement therapy for the treatment of Fabry disease. It is a recombinant human α-galactosidase-A. It is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme.
Classification
Enzyme
Drug classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297801
ChEBI ID—
PubChem CID—
DrugBankDB14992
UNII ID8M7V7Q6537 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 104 documents
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Safety
Black-box Warning
Black-box warning for: Elfabrio
Adverse Events
Top Adverse Reactions
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24 adverse events reported
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