Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 120 |
| INN | Evinacumab |
| Status | Approved |
| Drug code(s) | REGN1500 |
| Brand name | Evkeeza |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Velocimmune) |
| Target(s) | ANGPTL3 |
| Indications of clinical studies | Homozygous Familial Hypercholesterolemia, Hypertriglyceridemia, Hypercholesterolemia |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2012 |
| Start of Phase 2 | March 01, 2015 |
| Start of Phase 3 | January 18, 2018 |
| Date BLA/NDA submitted to FDA | February 28, 2020 |
| Year of first approval (global) | 2021 |
| Date of first US approval | February 11, 2021 |
| INN, US product name | Evinacumab, evinacumab-dgnb |
| US or EU approved indications | Add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | June 17, 2021: Authorized in EU. Evinacumab was granted rolling review in February 2020, as a benefit of its Breakthrough Therapy designation. The BLA application was submitted in 3 segments, with the final segment submitted on June 11, 2020. The evinacumab BLA was granted Priority Review during filing on August 11, 2020. March 2020, the Company presented positive, detailed results from the Phase 3 trial in patients with HoFH. The Company has also initiated a rolling BLA submission for HoFH and plans to submit an MAA in the EU in the second half of 2020. Feb 2020: Regeneron plans regulatory submission in 2020. August 14, 2019 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia, Results of 2 Phase 1 studies published in Circulation. 2019 Jun 27. doi: 10.1161/CIRCULATIONAHA.118.039107. NCT03409744 Phase 3 study recruiting as of Jan 24, 2018; NCT03399786 Phase 3 study started recruiting January 18, 2018. May 24, 2017: An analysis published today in the New England Journal of Medicine (NEJM) showed that people with inactivating mutations of the ANGPTL3 gene have significantly reduced risk of coronary artery disease (CAD) and significantly lower levels of key blood lipids including triglycerides and low-density lipoprotein cholesterol (LDL-C, or "bad cholesterol"). Data also included in this publication showed that blocking ANGPTL3 activity with evinacumab exhibited similar lipid-lowering effects in animal models and a first-in-human clinical study. April 6, 2017: Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial Hypercholesterolemia (HoFH), an inherited disorder that can lead to premature cardiovascular disease due to very high levels of LDL cholesterol. NCT02265952 Phase 2 study started in March 2015. Phase 1 study in patients recruiting as of April 2014 |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
REGN1500 was derived using Regeneron’s Velocimmune® technology platform and is a fully human monoclonal antibody with high affinity to ANGPTL3 from multiple species (mouse, rat, monkey, and human). REGN1500 has a human IgG4 constant region with a stabilizing mutation in the hinge region (serine to proline in position 108 in GenBank #P01864 to minimize half-antibody formation. S228P hinge mutation.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |