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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FDA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Repatha (discontinued: Repatha)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| repatha | Biologic Licensing Application | 2026-08-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | — | D006937 | — |
| atherosclerosis | EFO_0003914 | D050197 | I25.1 |
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
165 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 | — | — | — | 5 | 15 | 4 | 4 | 26 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 2 | 3 | 12 | 1 | 1 | 19 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 3 | 6 | 2 | 1 | 10 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 3 | 1 | 6 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 3 | 2 | 5 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | 2 | 2 | 5 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | 1 | 2 | 1 | — | 3 |
| Atherosclerotic plaque | D058226 | HP_0031678 | I70 | — | — | — | 2 | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | — | 2 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | — | — | 1 | — | 13 | — | — | 14 |
| Hyperlipoproteinemias | D006951 | — | — | 1 | — | 5 | — | 1 | 7 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | 2 | 3 |
| Coronary disease | D003327 | — | — | — | — | 2 | — | 1 | 3 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 2 | 1 | — | — | 3 |
| Multiple endocrine neoplasia type 1 | D018761 | — | E31.21 | — | — | 1 | — | — | 1 |
| Syndrome | D013577 | — | — | — | — | 1 | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | — | — | — | 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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2364655 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| 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
No data
Financial
Revenue by drug
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Repatha – Amgen
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Estimated US medical usage
Evolocumab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,396 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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158,590 adverse events reported
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