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Drug ReportsSebelipase alfa
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
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
kanumaBiologic Licensing Application2024-07-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
inborn errors lipid metabolism—D008052—
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
9 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_75233E75.5252—29
Failure to thriveD005183———11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Fabry diseaseD000795Orphanet_324E75.2112———2
Cholesterol ester storage diseaseD015217——12———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis ivD009085—E76.2101————1
Glycogen storage disease type iiD006009Orphanet_365E74.021————1
Gaucher diseaseD005776Orphanet_355E75.221————1
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)Loading
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Kanuma – Alexion Pharmaceuticals
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Kanuma – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 434 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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