Canakinumab Approved Naked monospecific

Antibody Information

Entry ID	9
INN	Canakinumab
Status	Approved
Drug code(s)	ACZ885
Brand name	Ilaris
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 (GenPharm/Medarex/BMS transgenic mouse platform Ultimab)

Therapeutic information

Target(s)	IL-1 beta
Indications of clinical studies	COVID-19, Cryopyrin-Associated Periodic Syndromes, Rheumatoid arthritis, wet age-related macular degeneration, Atherosclerosis and Either T2DM or IGT, Type 2 Diabetes, gout, juvenile arthritis
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)	August 15, 2003
Start of Phase 2	August 15, 2005
Start of Phase 3	July 15, 2007
Date BLA/NDA submitted to FDA	December 17, 2008
Year of first approval (global)	2009
Date of first US approval	June 17, 2009
INN, US product name	Canakinumab
US or EU approved indications	Adult-onset Still's disease, Juvenile Rheumatoid Arthritis, Cryopyrin (CIAS1)-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor-Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome / Mevalonate Kinase Deficiency, Familial Mediterranean Fever in combination with colchicine

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Novartis Pharmaceuticals
Licensee/Partner	None
Comments about company or candidate	US orphan
Full address of company	Basel, Switzerland Europe Switzerland https://www.novartis.com/contacts