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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
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
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
AldurazymelaronidaseBioMarin PharmaceuticalN-125058 RX2003-04-30
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
aldurazymeBiologic Licensing Application2019-12-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucopolysaccharidosis i—D008059E76.0
Agency Specific
FDA
EMA
Expiration
Code
laronidase, Aldurazyme, BioMarin Pharmaceutical Inc.
2110-04-30Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB05: Laronidase
HCPCS
Code
Description
J1931
Injection, laronidase, 0.1 mg
Clinical
Clinical Trials
18 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 iD008059E76.05334317
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lysosomal storage diseasesD0164642———13
Spinal cord compressionD013117EFO_1001845G95.202————2
Mucopolysaccharidosis ivD009085E76.2101————1
Glycogen storage disease type iiD006009Orphanet_365E74.021————1
Wolman diseaseD015223Orphanet_75233E75.51————1
Gaucher diseaseD005776Orphanet_355E75.221————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825G31.84————11
Hematopoietic stem cell transplantationD018380————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLARONIDASE
INNlaronidase
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 classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201595
ChEBI ID—
PubChem CID—
DrugBankDB00090
UNII IDWP58SVM6R4 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Aldurazyme - BioMarin Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 608 documents
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Safety
Black-box Warning
Black-box warning for: Aldurazyme
Adverse Events
Top Adverse Reactions
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42,662 adverse events reported
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