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
Trade Name
FDA
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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 |
|---|---|---|---|---|---|
| Brineura | cerliponase alfa | BioMarin Pharmaceutical | N-761052 RX | 2017-04-27 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brineura | Biologic Licensing Application | 2024-08-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neuronal ceroid-lipofuscinoses | — | D009472 | E75.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
cerliponase alfa, Brineura, BioMarin Pharmaceutical Inc. | |||
| 2024-04-27 | Orphan excl. | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J0567 | Injection, cerliponase alfa, 1 mg |
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuronal ceroid-lipofuscinoses | D009472 | — | E75.4 | 3 | 4 | — | — | 3 | 7 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | 1 | — | — | — | 1 |
| Disease progression | D018450 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CERLIPONASE ALFA |
| INN | cerliponase 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 class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 151662-36-1 |
| RxCUI | 1922436 |
| ChEMBL ID | CHEMBL3544921 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13173 |
| UNII ID | X8R2D92QP1 (ChemIDplus, GSRS) |
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Brineura – BioMarin Pharmaceutical
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Additional graphs summarizing 322 documents
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Safety
Black-box Warning
Black-box warning for: Brineura
Adverse Events
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387 adverse events reported
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