Repatha(evolocumab)
Repatha (evolocumab) is an antibody pharmaceutical. Evolocumab was first approved as Repatha on 2015-07-17. It is used to treat atherosclerosis and hypercholesterolemia in the USA. It has been approved in Europe to treat dyslipidemias and hypercholesterolemia. The pharmaceutical is active against proprotein convertase subtilisin/kexin type 9.
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Commercial
Trade Name
FDA
EMA
Repatha
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)
Evolocumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Repatha | evolocumab | Amgen | N-125522 RX | 2015-08-27 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
repatha | Biologic Licensing Application | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
atherosclerosis | EFO_0003914 | D050197 | I25.1 |
hypercholesterolemia | HP_0003124 | D006937 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
evolocumab, Repatha, Amgen Inc. | |||
2028-09-24 | Orphan excl. |
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypercholesterolemia | D006937 | HP_0003124 | — | 3 | 11 | 2 | 2 | 18 | |
Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 2 | 3 | 10 | 2 | — | 17 |
Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 4 | 5 | 2 | 1 | 10 |
Acute coronary syndrome | D054058 | EFO_0005672 | — | 2 | 1 | 2 | 3 | 8 | |
Dyslipidemias | D050171 | HP_0003119 | — | — | 5 | 1 | 2 | 8 | |
Coronary artery disease | D003324 | I25.1 | — | 1 | 1 | 3 | 2 | 7 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 4 | — | 6 |
St elevation myocardial infarction | D000072657 | — | 1 | — | 3 | — | 4 | ||
Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | 2 | 1 | 4 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Coronary disease | D003327 | — | — | 1 | — | 1 | 2 | ||
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
Covid-19 | D000086382 | U07.1 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
Glioblastoma | D005909 | EFO_0000515 | 1 | — | — | — | — | 1 | |
Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | EVOLOCUMAB |
INN | evolocumab |
Description | Evolocumab (human mab) |
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 1256937-27-5 |
RxCUI | 1665684 |
ChEMBL ID | CHEMBL2364655 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB09303 |
UNII ID | LKC0U3A8NJ (ChemIDplus, GSRS) |
Target
Agency Approved
PCSK9
PCSK9
Organism
Homo sapiens
Gene name
PCSK9
Gene synonyms
NARC1
NCBI Gene ID
Protein name
proprotein convertase subtilisin/kexin type 9
Protein synonyms
convertase subtilisin/kexin type 9 preproprotein, NARC-1, neural apoptosis regulated convertase 1, Neural apoptosis-regulated convertase 1, PC9, Proprotein convertase 9, Subtilisin/kexin-like protease PC9
Uniprot ID
Mouse ortholog
Pcsk9 (100102)
proprotein convertase subtilisin/kexin type 9 (Q8CFT6)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Repatha - Amgen
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,150 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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43,206 adverse events reported
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