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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
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 |
|---|---|---|---|---|---|
| Evkeeza | evinacumab-dgnb | Regeneron Pharmaceuticals | N-761181 RX | 2021-02-11 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| evkeeza | Biologic Licensing Application | 2025-09-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
evinacumab, Evkeeza, Regeneron Pharmaceuticals, Inc. | |||
| 2030-03-21 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1305 | Injection, evinacumab-dgnb, 5mg |
Clinical
Clinical Trials
13 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | — | — | — | 2 | 3 | — | 2 | 7 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 1 | 3 | — | 2 | 6 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | 1 | 3 | — | 2 | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 1 | 2 | — | — | 1 | 4 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Metabolic brain diseases | D001928 | — | G93.41 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipoproteinemia type iii | D006952 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Evinacumab |
| INN | evinacumab |
| Description | Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH).
|
| Classification | Antibody |
| Drug class | monoclonal antibodies; vinca alkaloids |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545191 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15354 |
| UNII ID | T8B2ORP1DW (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
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Variants
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Financial
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Evkeeza – Regeneron Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 701 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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154 adverse events reported
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