Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 125 |
| INN | Sarilumab |
| Status | Approved |
| Drug code(s) | REGN88, SAR153191 |
| Brand name | Kevzara |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Velocimmune) |
| Target(s) | IL-6R |
| Indications of clinical studies | COVID-19, Rheumatoid Arthritis, Ankylosing Spondylitis, |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2007 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2010 |
| Date BLA/NDA submitted to FDA | October 30, 2015 |
| Year of first approval (global) | 2017 |
| Date of first US approval | May 22, 2017 |
| INN, US product name | Sarilumab |
| US or EU approved indications | Rheumatoid arthritis |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in Canada on Jan 12, 2017; Approved in US May 22, 2017; Approved in EU on June 23, 2017 BLA submitted in October 2015. PDUFA date 30 October 2016. May 2015: Sarilumab meets Phase III RA endpoints |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |