Fabrazyme(agalsidase beta)
Fabrazyme (agalsidase beta) is an enzyme pharmaceutical. Agalsidase beta was first approved as Fabrazyme on 2001-08-03. 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
Fabrazyme
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fabrazyme | Biologic Licensing Application | 2025-08-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fabry disease | Orphanet_324 | D000795 | E75.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
agalsidase beta, Fabrazyme, Genzyme Corporation | |||
| 2028-03-11 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0180 | Injection, agalsidase beta, 1 mg |
Clinical
Clinical Trials
91 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fabry disease | D000795 | Orphanet_324 | E75.21 | 8 | 16 | 19 | 13 | 32 | 83 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | 2 | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 1 | — | — | — | 1 | 2 |
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Hyperglycemia | D006943 | — | R73.9 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Proteinuria | D011507 | — | R80 | — | — | — | — | 2 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 2 | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | — | 1 | 1 |
| Alopecia | D000505 | — | L64 | — | — | — | — | 1 | 1 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | — | — | — | 1 | 1 |
| Colic | D003085 | — | R10.83 | — | — | — | — | 1 | 1 |
| Flatulence | D005414 | — | R14.3 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Agalsidase beta |
| INN | agalsidase beta |
| Description | Fabrazyme (agalsidase beta) is an enzyme pharmaceutical. Agalsidase beta was first approved as Fabrazyme on 2001-08-03. It is used to treat fabry disease in the USA. It has been approved in Europe to treat fabry disease. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108888 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | RZD65TSM9U (ChemIDplus, GSRS) |
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Fabrazyme – Sanofi
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Trends
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Additional graphs summarizing 9,782 documents
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Safety
Black-box Warning
Black-box warning for: Fabrazyme
Adverse Events
Top Adverse Reactions
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10,262 adverse events reported
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