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Drug ReportsLaronidase
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2024-10-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucopolysaccharidosis iD008059E76.0
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
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 iD008059E76.013854529
MucopolysaccharidosesD009083E76.312854528
SyndromeD0135775443216
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis iiD016532E76.11112
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825G31.8422
Hematopoietic stem cell transplantationD01838011
HypercholesterolemiaD00693711
SplenectomyD01315611
Lung diseasesD008171EFO_0003818J98.411
ThrombocytopeniaD013921HP_0001873D69.611
Interstitial lung diseasesD017563EFO_0004244J84.911
Niemann-pick diseasesD009542E75.2411
Type a niemann-pick diseaseD052536EFO_1001380E75.24011
SplenomegalyD013163R16.111
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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)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201595
ChEBI ID
PubChem CID
DrugBankDB00090
UNII IDWP58SVM6R4 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Aldurazyme BioMarin Pharmaceutical
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 830 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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