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| Stem definition | Drug id | CAS RN |
|---|---|---|
| human origin | 5449 | 1446419-85-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Evinacumab-dgnb is a recombinant human monoclonal antibody that binds to and inhibits ANGPTL3. ANGPTL3 is a member of the angiopoietin-like protein family that is expressed primarily in the liver and plays a role in the regulation of lipid metabolism by inhibiting lipoprotein lipase (LPL) and endothelial lipase (EL). Evinacumab-dgnb inhibition of ANGPTL3 leads to reduction in LDL-C, HDL-C, and triglycerides (TG). Evinacumab-dgnb reduces LDL-C independent of the presence of LDL receptor (LDLR) by promoting very low-density lipoprotein (VLDL) processing and clearance upstream of LDL formation. Evinacumab-dgnb blockade of ANGPTL3 lowers TG and HDL-C by rescuing LPL and EL activities, respectively.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 11, 2021 | FDA | REGENERON PHARMACEUTICALS | |
| June 17, 2021 | EMA | Regeneron Ireland Designated Activity Company (DAC) |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic steatosis | 103.39 | 67.12 | 20 | 93 | 36925 | 90591409 |
| International normalised ratio increased | 74.89 | 67.12 | 16 | 97 | 47300 | 90581034 |
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| Source | Code | Description |
|---|---|---|
| ATC | C10AX17 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents |
| MeSH PA | D000924 | Anticholesteremic Agents |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D057847 | Lipid Regulating Agents |
| FDA EPC | N0000193915 | Angiopoietin-like 3 Inhibitor |
| FDA MoA | N0000193916 | Angiopoietin-like 3 Inhibitors |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35821 | anticholesteremic drug |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Homozygous familial hypercholesterolemia | indication | 238078005 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Angiopoietin-related protein 3 | Secreted | INHIBITOR | Kd | 9.04 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11753 | KEGG_DRUG |
| T8B2ORP1DW | UNII |
| C4508522 | UMLSCUI |
| CHEBI:755506 | CHEBI |
| CHEMBL3545191 | ChEMBL_ID |
| DB15354 | DRUGBANK_ID |
| 10013 | INN_ID |
| C000621590 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8717 | IUPHAR_LIGAND_ID |
| 1149149009 | SNOMEDCT_US |
| 1149184008 | SNOMEDCT_US |
| 4040110 | VANDF |
| 4040111 | VANDF |
| 343531 | MMSL |
| 39317 | MMSL |
| d09713 | MMSL |
| 018635 | NDDF |
| 2478335 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Evkeeza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-010 | INJECTION, SOLUTION, CONCENTRATE | 150 mg | INTRAVENOUS | BLA | 29 sections |
| Evkeeza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61755-013 | INJECTION, SOLUTION, CONCENTRATE | 150 mg | INTRAVENOUS | BLA | 29 sections |