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

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

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/