Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 11 |
| INN | Secukinumab |
| Status | Approved |
| Drug code(s) | AIN457 |
| Brand name | Cosentyx |
| 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 (Medarex/BMS) |
| Target(s) | IL-17A |
| Indications of clinical studies | Atopic dermatitis, Rheumatoid Arthritis, Plaque-type Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Multiple Sclerosis, Crohn's Disease, Uveitis, Asthma |
| Primary therapeutic area | Immune-mediated / inflammatory 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 02, 2005 |
| Start of Phase 2 | |
| Start of Phase 3 | May 15, 2009 |
| Date BLA/NDA submitted to FDA | October 24, 2013 |
| Year of first approval (global) | 2014 |
| Date of first US approval | January 21, 2015 |
| INN, US product name | Secukinumab |
| US or EU approved indications | US 2023: Treatment of adults with moderate-to-severe hidradenitis suppurativa Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis; April 29, 2020: European Commission approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis. FDA also approved Cosentyx (secukinumab) for active non-radiographic axial spondyloarthritis; July 2020: European Commission granted the approval for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years. |
| Company | Novartis Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 3 in Lupus Nephritis not yet recruiting as of 11/29/2019. BLA submitted in October 2013; listed by EMA as under review as of December 5, 2013. PDUFA date Oct 2014. Approved in Japan 12/26/2014; approved 1/21/2015 in US; also approved in EU in 2015 |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |