Belimumab Approved Naked monospecific

Antibody Information

Entry ID	162
INN	Belimumab
Status	Approved
Drug code(s)	GSK1550188, HGS-1006, LSB, LymphoStat-B
Brand name	Benlysta
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	lambda
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Phage display (CAT library)

Therapeutic information

Target(s)	BAFF
Indications of clinical studies	Systemic Lupus Erythematosus, rheumatoid arthritis, Sjögren's Syndrome, Symptomatic Waldenstroms Macroglobulinaemia, Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation
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)	November 15, 2001
Start of Phase 2	September 25, 2003
Start of Phase 3	December 15, 2006
Date BLA/NDA submitted to FDA	June 09, 2010
Year of first approval (global)	2011
Date of first US approval	March 09, 2011
INN, US product name	Belimumab
US or EU approved indications	Systemic Lupus Erythematosus

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	GlaxoSmithKline
Licensee/Partner	None
Comments about company or candidate	Fast track; GlaxoSmithKline acquired Human Genome Sciences in 2012.
Full address of company	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/