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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
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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
Kanumasebelipase alfaAlexion PharmaceuticalsN-125561 RX2015-12-08
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
kanumaBiologic Licensing Application2020-08-12
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
sebelipase alfa, Kanuma, Alexion Pharmaceuticals, Inc.
2122-12-08Orphan 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
— A16AB14: Sebelipase alfa
HCPCS
Code
Description
J2840
Injection, sebelipase alfa, 1 mg
Clinical
Clinical Trials
7 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
Wolman diseaseD015223Orphanet_75233E75.5—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fabry diseaseD000795E75.2112———2
Cholesterol ester storage diseaseD01521712———2
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 nameSEBELIPASE ALFA
INNsebelipase 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 classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1276027-63-4
RxCUI1726975
ChEMBL IDCHEMBL3039537
ChEBI ID—
PubChem CID—
DrugBankDB11563
UNII IDK4YTU42T8G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kanuma - Alexion Pharmaceuticals
$
€
£
₣
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Kanuma - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 362 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,722 adverse events reported
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