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
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 |
|---|---|---|---|---|---|
| Elfabrio | pegunigalsidase alfa-iwxj | Chiesi Farmaceutici | N-761161 RX | 2023-05-09 | 1 products |
Labels
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fabry disease | Orphanet_324 | D000795 | E75.21 |
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Clinical
Clinical Trials
12 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 disease | D000795 | Orphanet_324 | E75.21 | 2 | 3 | 7 | — | 3 | 12 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegunigalsidase alfa |
| INN | pegunigalsidase 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.
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| Classification | Enzyme |
| Drug class | enzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297801 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14992 |
| UNII ID | 8M7V7Q6537 (ChemIDplus, GSRS) |
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