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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5720 | 1644392-61-9 |
| Molecule | Description |
|---|---|
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Synonyms:
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Pegunigalsidase alfa is a pegylated recombinant form of human alpha-galactosidase-A. The amino acid sequence of the recombinant form is similar to the naturally occurring human enzyme. Pegunigalsidase alfa supplements or replaces alpha-galactosidase-A, the enzyme that catalyses the hydrolysis of the terminal α-galactosyl moieties of oligosaccharides and polysaccharides in the lysosome, reducing the amount of accumulation of globotriaosylceramide (Gb3) and globotriaosylsphingosine (Lyso-Gb3).
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 4, 2023 | EMA | CHIESI FARMACEUTICI S.P.A | |
| May 9, 2023 | FDA | CHIESI FARMACEUTICI S.P.A |
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| Source | Code | Description |
|---|---|---|
| ATC | A16AB20 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA CS | M0000794 | alpha-Glucosidases |
| FDA EPC | N0000175822 | Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Fabry's disease | indication | 16652001 | DOID:14499 |
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| ID | Source |
|---|---|
| CHEBI:757247 | CHEBI |
| CHEMBL4297801 | ChEMBL_ID |
| C000731937 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14992 | DRUGBANK_ID |
| 2054151000122106 | SNOMEDCT_US |
| 4042264 | VANDF |
| 4042265 | VANDF |
| C5139798 | UMLSCUI |
| 10304 | INN_ID |
| 121488171 | PUBCHEM_CID |
| 367044 | MMSL |
| 41517 | MMSL |
| d10044 | MMSL |
| 019422 | NDDF |
| D11685 | KEGG_DRUG |
| 8M7V7Q6537 | UNII |
| 2637445 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ELFABRIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-160 | INJECTION, SOLUTION, CONCENTRATE | 20 mg | INTRAVENOUS | BLA | 24 sections |
| ELFABRIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10122-165 | INJECTION, SOLUTION, CONCENTRATE | 5 mg | INTRAVENOUS | BLA | 24 sections |