Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 19 |
| INN | Erenumab |
| Status | Approved |
| Drug code(s) | AMG 334 |
| Brand name | Aimovig |
| 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) | CGRP receptor |
| Indications of clinical studies | Migraine, Vasomotor Symptoms; Hot Flashes |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2012 |
| Start of Phase 2 | August 15, 2013 |
| Start of Phase 3 | July 15, 2015 |
| Date BLA/NDA submitted to FDA | May 17, 2017 |
| Year of first approval (global) | 2018 |
| Date of first US approval | May 17, 2018 |
| INN, US product name | Erenumab, erenumab-aooe |
| US or EU approved indications | Preventive treatment of migraine in adults |
| Company | Amgen |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in US on May 17, 2018. Sep 2016: Phase 3 migraine study end point met. Two Phase 3 studies in migraine started in July 2015. Positive Phase 2 study results reported in May 2015. Phase 2 studies recruiting as of Feb 2014 |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
GPCR target. Ab generation: XenoMouse were immunized with purified soluble CGRP receptor protein as the antigen. Soluble CGRP receptor polypeptides containing the N-terminal extracellular domains (ECDs) of human CRLR (amino acids 1–138 of GenBank accession no. AAA62158) and human RAMP1 (amino acids 1 to 117 of GenBank accession no. CAA04472) were generated by transiently cotransfecting 293 6E cells. Hybridomas are generated from a pool of mice with the highest sera titer using a standard protocol (Kearney et al., 1979) and AMG 334 is identified through screening assays including binding competition, functional blocking, and receptor selectivity against the human CGRP receptor (Journal of Pharmacology and Experimental Therapeutics January 2016, 356 (1) 223-231; DOI: https://doi.org/10.1124/jpet.115.227793)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |