Aldurazyme(laronidase)
Aldurazyme (laronidase) is an enzyme pharmaceutical. Laronidase was first approved as Aldurazyme on 2003-04-30. It is used to treat mucopolysaccharidosis i in the USA. It has been approved in Europe to treat mucopolysaccharidosis i.
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Commercial
Trade Name
FDA
EMA
Aldurazyme
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)
Laronidase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Aldurazyme | laronidase | BioMarin Pharmaceutical | N-125058 RX | 2003-04-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aldurazyme | Biologic Licensing Application | 2024-10-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| mucopolysaccharidosis i | — | D008059 | E76.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
laronidase, Aldurazyme, BioMarin Pharmaceutical Inc. | |||
| 2110-04-30 | Orphan excl. | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J1931 | Injection, laronidase, 0.1 mg |
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidoses | D009083 | — | E76.3 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| Lysosomal storage diseases | D016464 | — | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Laronidase |
| INN | laronidase |
| Description | Aldurazyme (laronidase) is an enzyme pharmaceutical. Laronidase was first approved as Aldurazyme on 2003-06-09. It is used to treat mucopolysaccharidosis i in the USA. It has been approved in Europe to treat mucopolysaccharidosis i. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201595 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00090 |
| UNII ID | WP58SVM6R4 (ChemIDplus, GSRS) |
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Aldurazyme – BioMarin Pharmaceutical
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Additional graphs summarizing 828 documents
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Safety
Black-box Warning
Black-box warning for: Aldurazyme
Adverse Events
Top Adverse Reactions
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4,165 adverse events reported
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