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Palynziq(pegvaliase)
Palynziq (pegvaliase) is an enzyme pharmaceutical. Pegvaliase was first approved as Palynziq on 2018-05-24. It is used to treat phenylketonurias in the USA. It has been approved in Europe to treat phenylketonurias.
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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
Palynziq
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)
Pegvaliase
Tradename
Proper name
Company
Number
Date
Products
Palynziqpegvaliase-pqpzBioMarin PharmaceuticalN-761079 RX2018-05-24
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
palynziqBiologic Licensing Application2020-11-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
phenylketonurias—D010661E70.0
Agency Specific
FDA
EMA
Expiration
Code
pegvaliase, Palynziq, BioMarin Pharmaceutical Inc.
2025-05-24Orphan 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
— A16AB19: Pegvaliase
HCPCS
No data
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PhenylketonuriasD010661E70.0144—312
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Maternal phenylketonuriaD017042————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePEGVALIASE
INNpegvaliase
Description
Pegvaliase, sold under the brand name Palynziq, is a medication for the treatment of the genetic disease phenylketonuria. Chemically, it is a pegylated derivative of the enzyme phenylalanine ammonia-lyase that metabolizes phenylalanine to reduce its blood levels.
Classification
Enzyme
Drug classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1585984-95-7
RxCUI—
ChEMBL IDCHEMBL4297802
ChEBI ID—
PubChem CID—
DrugBankDB12839
UNII IDN6UAH27EUV (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Palynziq - BioMarin Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 174 documents
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Safety
Black-box Warning
Black-box warning for: Palynziq
Adverse Events
Top Adverse Reactions
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10,414 adverse events reported
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