Evinacumab is a fully human monoclonal antibody and active pharmaceutical ingredient used as a lipid-lowering therapeutic agent. It targets angiopoietin-like 3 (ANGPTL3), a protein involved in the regulation of lipid metabolism.
Evinacumab binds to ANGPTL3 and inhibits its activity, resulting in reductions in multiple lipid parameters. It is used as an adjunct to other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia (HoFH).
Evinacumab is a recombinant human monoclonal antibody of the IgG4 subclass. By binding to ANGPTL3, it helps restore the activity of lipoprotein and endothelial lipases that are normally inhibited by ANGPTL3.
CAS Number: 1345754-76-6
Molecular Formula: Not applicable as a conventional small molecule; recombinant monoclonal antibody
Molecular Weight: Approximately 146 kDa
Evinacumab binds to ANGPTL3 and inhibits its interaction with lipoprotein lipase and endothelial lipase.
Its pharmacological effects include:
Importantly, its LDL-lowering activity is largely independent of the LDL receptor, which makes ANGPTL3 inhibition particularly relevant in homozygous familial hypercholesterolemia.
Evinacumab is used as an adjunct to other lipid-lowering therapies for:
The exact indication, age range, dosage and administration requirements depend on the approved product labeling and applicable regulatory authority.
Evinacumab is a biological API / monoclonal antibody drug substance rather than a conventional chemically synthesized small-molecule API.
Quality evaluation of monoclonal antibodies generally involves characterization of:
Pharmaceutical-grade Evinacumab should be manufactured under appropriate biopharmaceutical GMP controls and according to the applicable approved specification and regulatory requirements.
For a biological product, a qualified supplier should provide appropriate Certificate of Analysis (CoA), analytical characterization documentation, SDS/MSDS where applicable, batch traceability and regulatory documentation.
Evinacumab drug substance and finished biological formulations require controlled temperature and handling conditions because monoclonal antibodies are sensitive to temperature excursions and physical stress. Storage conditions should always follow the approved manufacturer's specification.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |