Kanuma(sebelipase alfa)
Kanuma (sebelipase alfa) is an enzyme pharmaceutical. Sebelipase alfa was first approved as Kanuma on 2015-08-28. It has been approved in Europe to treat inborn errors lipid metabolism.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Kanuma
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)
Sebelipase alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Kanuma | sebelipase alfa | Alexion Pharmaceuticals | N-125561 RX | 2015-12-08 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kanuma | Biologic Licensing Application | 2024-07-17 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
sebelipase alfa, Kanuma, Alexion Pharmaceuticals, Inc. | |||
| 2122-12-08 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2840 | Injection, sebelipase alfa, 1 mg |
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wolman disease | D015223 | Orphanet_75233 | E75.5 | 2 | 5 | 2 | — | 2 | 9 |
| Failure to thrive | D005183 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fabry disease | D000795 | Orphanet_324 | E75.21 | 1 | 2 | — | — | — | 2 |
| Cholesterol ester storage disease | D015217 | — | — | 1 | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 1 | — | — | — | — | 1 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sebelipase alfa |
| INN | sebelipase alfa |
| Description | Sebelipase alfa, sold under the brand name Kanuma, is a recombinant form of the enzyme lysosomal acid lipase (LAL) that is used as a medication for the treatment of lysosomal acid lipase deficiency (LAL-D). It is administered via intraveneous infusion. It was approved for medical use in the European Union and in the United States in 2015.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1276027-63-4 |
| RxCUI | 1726975 |
| ChEMBL ID | CHEMBL3039537 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11563 |
| UNII ID | K4YTU42T8G (ChemIDplus, GSRS) |
Target
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Variants
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Kanuma – Alexion Pharmaceuticals
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Kanuma – AstraZeneca
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 439 documents
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Safety
Black-box Warning
Black-box warning for: Kanuma
Adverse Events
Top Adverse Reactions
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544 adverse events reported
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