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Evkeeza(evinacumab)
Evkeeza (evinacumab) is an antibody pharmaceutical. Evinacumab was first approved as Evkeeza on 2021-02-11. It has been approved in Europe to treat hypercholesterolemia. The pharmaceutical is active against angiopoietin-related protein 3.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Evkeeza
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)
Evinacumab
Tradename
Proper name
Company
Number
Date
Products
Evkeezaevinacumab-dgnbRegeneron PharmaceuticalsN-761181 RX2021-02-11
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
evkeezaBiologic Licensing Application2021-02-11
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
evinacumab, Evkeeza, Regeneron Pharmaceuticals, Inc.
2028-02-11Orphan excl.
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AX: Other lipid modifying agents in atc
— C10AX17: Evinacumab
HCPCS
Code
Description
J1305
Injection, evinacumab-dgnb, 5mg
Clinical
Clinical Trials
11 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
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00—14——5
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertriglyceridemiaD015228EFO_000421112———3
HypercholesterolemiaD006937HP_0003124—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Metabolic brain diseasesD001928G93.411————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEVINACUMAB
INNevinacumab
Description
Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH).
Classification
Antibody
Drug classmonoclonal antibodies; vinca alkaloids
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1446419-85-7
RxCUI—
ChEMBL IDCHEMBL3545191
ChEBI ID—
PubChem CID—
DrugBankDB15354
UNII IDT8B2ORP1DW (ChemIDplus, GSRS)
Target
Agency Approved
ANGPTL3
ANGPTL3
Organism
Homo sapiens
Gene name
ANGPTL3
Gene synonyms
ANGPT5
NCBI Gene ID
27329
Protein name
angiopoietin-related protein 3
Protein synonyms
ANG-5, angiopoietin 5, Angiopoietin-5, Angiopoietin-like protein 3
Uniprot ID
Q9Y5C1
Mouse ortholog
Angptl3 (30924)
angiopoietin-related protein 3 (Q9R182)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Evkeeza - Regeneron Pharmaceuticals
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 330 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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840 adverse events reported
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