Agalsidase alfa
Replagal (agalsidase alfa) is an enzyme pharmaceutical. Agalsidase alfa was first approved as Replagal on 2001-08-03. It is used to treat flatulence in the USA. It has been approved in Europe to treat fabry disease.
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Commercial
Trade Name
FDA
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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FDA
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Agency Specific
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Patent Expiration
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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
— A16AB03: Agalsidase alfa
HCPCS
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Clinical
Clinical Trials
73 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
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Total
Fabry diseaseD000795Orphanet_324E75.21——1—12
Indications Phases 2
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Left ventricular hypertrophyD017379EFO_0003896—————11
Hypertrophic cardiomyopathyD002312EFO_0000538I42.1————11
CardiomyopathiesD009202EFO_0000318I42————11
Lysosomal storage diseasesD016464——————11
HypertrophyD006984EFO_0002460—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAgalsidase alfa
INNagalsidase alfa
Description
Replagal (agalsidase alfa) is an enzyme pharmaceutical. Agalsidase alfa was first approved as Replagal on 2001-08-03. It has been approved in Europe to treat fabry disease.
Classification
Enzyme
Drug classenzymes
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB1R46, 1R47
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108214
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID2HLC17MX9G (ChemIDplus, GSRS)
Target
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Replagal – Takeda
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Replagal – Shire
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,801 documents
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Safety
Black-box Warning
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206 adverse events reported
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