Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 17 |
| INN | Evolocumab |
| Status | Approved |
| Drug code(s) | AMG 145 |
| Brand name | Repatha |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Xenomouse) |
| Target(s) | PCSK9 |
| Indications of clinical studies | Hypercholesterolemia and High Risk for Cardiovascular Events, homozygous familial hypercholesterolemia |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2009 |
| Start of Phase 2 | |
| Start of Phase 3 | January 15, 2012 |
| Date BLA/NDA submitted to FDA | August 27, 2014 |
| Year of first approval (global) | 2015 |
| Date of first US approval | August 27, 2015 |
| INN, US product name | Evolocumab |
| US or EU approved indications | High cholesterol. REPATHA is indicated: to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease; as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C); as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. |
| Company | Amgen |
| Licensee/Partner | Astellas |
| Comments about company or candidate | Partnership with Astellas for marketing in Japan. Approved in EU on July 22, 2015; approved in US on Aug 27, 2015 |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |