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Taliglucerase alfa
Elelyso (taliglucerase alfa) is an enzyme pharmaceutical. Taliglucerase alfa was first approved as Elelyso on 2012-05-01. It is used to treat gaucher disease in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Elelyso
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)
Taliglucerase alfa
Tradename
Proper name
Company
Number
Date
Products
Elelysotaliglucerase alfaPfizerN-22458 RX2012-05-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
elelysoBiologic Licensing Application2020-12-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gaucher diseaseOrphanet_355D005776E75.22
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
— A16AB11: Taliglucerase alfa
HCPCS
Code
Description
J3060
Injection, taliglucerase alfa, 10 units
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
Malignant pleural effusionD016066J91.01212612
Pleural effusionD010996J90—1—135
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80——4—15
Metabolic syndromeD024821EFO_0000195E88.81——1——1
Lung diseasesD008171EFO_0003818J98.4——1——1
MesotheliomaD008654C45——1——1
Malignant mesotheliomaD000086002——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic periodontitisD055113EFO_0006343K05.3—2———2
Knee osteoarthritisD020370EFO_0004616M17—1———1
Hip osteoarthritisD015207EFO_1000786M16—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD0022891————1
Lung neoplasmsD008175C34.901————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumothoraxD011030J93.11————22
Gestational diabetesD016640HP_0009800O24.4————11
Pleural diseasesD010995————11
Critical illnessD016638————11
CommunicationD003142————11
PleurisyD010998EFO_1001825R09.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTALIGLUCERASE ALFA
INNtaliglucerase alfa
Description
Taliglucerase alfa, sold under the brand name Elelyso among others, is a biopharmaceutical medication developed by Protalix and Pfizer.[full citation needed] The drug, a recombinant glucocerebrosidase used to treat Gaucher's disease, is the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration (FDA). Each vial has 200 units of taliglucerase alfa.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID37228-64-1
RxCUI—
ChEMBL IDCHEMBL1964120
ChEBI ID—
PubChem CID—
DrugBankDB08876
UNII ID0R4NLX88O4 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 378 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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631 adverse events reported
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