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Brineura(cerliponase alfa)
Brineura (cerliponase alfa) is an enzyme pharmaceutical. Cerliponase alfa was first approved as Brineura on 2017-04-27. It is used to treat neuronal ceroid-lipofuscinoses in the USA. It has been approved in Europe to treat neuronal ceroid-lipofuscinoses.
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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
Brineura
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)
Cerliponase alfa
Tradename
Proper name
Company
Number
Date
Products
Brineuracerliponase alfaBioMarin PharmaceuticalN-761052 RX2017-04-27
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
brineuraBiologic Licensing Application2020-07-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neuronal ceroid-lipofuscinoses—D009472E75.4
Agency Specific
FDA
EMA
Expiration
Code
cerliponase alfa, Brineura, BioMarin Pharmaceutical Inc.
2024-04-27Orphan 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
— A16AB17: Cerliponase alfa
HCPCS
Code
Description
J0567
Injection, cerliponase alfa, 1 mg
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neuronal ceroid-lipofuscinosesD009472E75.434——15
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 nameCERLIPONASE ALFA
INNcerliponase alfa
Description
Cerliponase alfa, marketed as Brineura, is an enzyme replacement treatment for Batten disease, a neurodegenerative lysosomal storage disease. Specifically, Cerliponase alfa is meant to slow loss of motor function in symptomatic children over three years old with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). The disease is also known as tripeptidyl peptidase-1 (TPP1) deficiency, a soluble lysosomal enzyme deficiency. Approved by the United States Food and Drug Administration (FDA) on 27 April 2017, this is the first treatment for a neuronal ceroid lipofuscinosis of its kind, acting to slow disease progression rather than palliatively treat symptoms by giving patients the TPP1 enzyme they are lacking.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID151662-36-1
RxCUI1922436
ChEMBL IDCHEMBL3544921
ChEBI ID—
PubChem CID—
DrugBankDB13173
UNII IDX8R2D92QP1 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Brineura - BioMarin Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 259 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,440 adverse events reported
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