Tocilizumab Approved Naked monospecific

Antibody Information

Entry ID	108
INN	Tocilizumab
Status	Approved
Drug code(s)	MRA, RHPM-1, RG1569
Brand name	RoActemra, Actemra
mAb sequence source	mAb humanized
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	None

Therapeutic information

Target(s)	IL-6R
Indications of clinical studies	COVID-19, Giant lymph node hyperplasia (Castleman's Disease), rheumatoid arthritis, multiple myeloma
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)	June 15, 1998
Start of Phase 2	February 15, 2000
Start of Phase 3
Date BLA/NDA submitted to FDA	November 19, 2007
Year of first approval (global)	2005
Date of first US approval	January 08, 2010
INN, US product name	Tocilizumab
US or EU approved indications	Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis. Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older; treatment for patients age 2 and older with active systemic juvenile idiopathic arthritis.

Description/comment

INN was fomerly atlizumab

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Hoffmann-La Roche
Licensee/Partner	None
Comments about company or candidate	Emergency use authorization granted by FDA on June 24, 2021 for COVID-19. First approved in Japan on April 11, 2005
Full address of company	Basel, Switzerland Europe Switzerland https://www.roche.com/about