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
No data
HCPCS
Code | Description |
|---|---|
| J1931 | Injection, laronidase, 0.1 mg |
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis i | D008059 | — | E76.0 | 13 | 8 | 5 | 4 | 5 | 29 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidoses | D009083 | — | E76.3 | 10 | 6 | 2 | — | 4 | 17 |
| Syndrome | D013577 | — | — | 2 | 3 | 2 | — | 1 | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | 1 | 1 | — | — | 1 | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lysosomal storage diseases | D016464 | — | — | 3 | — | — | — | 1 | 4 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | 1 | 2 |
| Spinal cord compression | D013117 | EFO_1001845 | G95.20 | 2 | — | — | — | — | 2 |
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 1 | — | — | — | — | 1 |
| Wolman disease | D015223 | Orphanet_75233 | E75.5 | 1 | — | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 2 | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 1 | 1 |
| Hypercholesterolemia | D006937 | — | — | — | — | — | — | 1 | 1 |
| Splenectomy | D013156 | — | — | — | — | — | — | 1 | 1 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | — | — | 1 | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | — | 1 | 1 |
| Niemann-pick diseases | D009542 | — | E75.24 | — | — | — | — | 1 | 1 |
| Splenomegaly | D013163 | — | R16.1 | — | — | — | — | 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) |
Target
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Variants
No data
Financial
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Aldurazyme – BioMarin Pharmaceutical
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 860 documents
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Safety
Black-box Warning
Black-box warning for: Aldurazyme
Adverse Events
Top Adverse Reactions
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4,360 adverse events reported
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