YAbS







Secukinumab Approved Naked monospecific

Antibody Information

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)

Therapeutic information

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

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
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 information

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

Description/comment

None

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None