YAbS







Sarilumab Approved Naked monospecific

Antibody Information

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)

Therapeutic information

Target(s) IL-6R
Indications of clinical studies COVID-19, Rheumatoid Arthritis, Ankylosing Spondylitis,
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, 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 information

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/

Description/comment

None

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None