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Drug ReportsIdursulfase beta
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
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
elapraseBiologic Licensing Application2024-12-26
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
27 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 iiD016532—E76.141094826
SyndromeD013577——2663516
MucopolysaccharidosesD009083—E76.32553415
Mucopolysaccharidosis iD008059—E76.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825—G31.84132——3
Mucopolysaccharidosis iiiD009084—E76.22—11——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis ivD009085—E76.2101————1
Glycogen storage disease type iiD006009Orphanet_365E74.021————1
Wolman diseaseD015223Orphanet_75233E75.51————1
Lysosomal storage diseasesD016464——1————1
Gaucher diseaseD005776Orphanet_355E75.221————1
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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB6IOZ
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297988
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID5GCF8EPY6R (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Elaprase – Takeda
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Elaprase – Shire
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 320 documents
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Safety
Black-box Warning
Black-box warning for: Elaprase
Adverse Events
Top Adverse Reactions
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1,930 adverse events reported
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