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.
Download report
Favorite
Top 200 Pharmaceuticals by Retail Sales
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
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
Show 17 more
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
View more details
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
$
€
£
₣
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 3,150 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
43,206 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more