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Drug ReportsAgalsidase beta
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
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
nervous system diseasesD009422
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Fabrazyme
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)
Agalsidase beta
Tradename
Proper name
Company
Number
Date
Products
Fabrazymeagalsidase betaSanofiN-103979 RX2003-04-24
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
fabrazymeBiologic Licensing Application2025-08-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
fabry diseaseOrphanet_324D000795E75.21
Agency Specific
FDA
EMA
Expiration
Code
agalsidase beta, Fabrazyme, Genzyme Corporation
2028-03-11Orphan 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
— A16AB04: Agalsidase beta
HCPCS
Code
Description
J0180
Injection, agalsidase beta, 1 mg
Clinical
Clinical Trials
92 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 diseaseD000795Orphanet_324E75.21—339520
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436—N18—1———1
Kidney diseasesD007674EFO_0003086N08—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AngiokeratomaD000794——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAgalsidase beta
INNagalsidase 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 classenzymes
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108888
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDRZD65TSM9U (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fabrazyme – Sanofi
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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 9,902 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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