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Idursulfase beta
Elaprase (idursulfase beta) is an enzyme pharmaceutical. Idursulfase beta was first approved as Elaprase on 2007-01-08. It has been approved in Europe to treat mucopolysaccharidosis II.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
elapraseBiologic Licensing Application2021-10-06
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
— A16AB16: Idursulfase beta
HCPCS
No data
Clinical
Clinical Trials
17 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 iiD016532E76.13864216
Mucopolysaccharidosis iD008059E76.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis iiiD009084E76.22—11——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIDURSULFASE BETA
INNidursulfase beta
Description
Elaprase (idursulfase beta) is an enzyme pharmaceutical. Idursulfase beta was first approved as Elaprase on 2007-01-08. It has been approved in Europe to treat mucopolysaccharidosis II.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)IDURSULFASE BETA
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB6IOZ
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297988
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID5GCF8EPY6R (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Elaprase - Takeda
$
€
£
₣
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Elaprase - Shire
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 276 documents
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Safety
Black-box Warning
Black-box warning for: Elaprase
Adverse Events
Top Adverse Reactions
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1,895 adverse events reported
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