Eculizumab Approved Naked monospecific

Antibody Information

Entry ID	26
INN	Eculizumab
Status	Approved
Drug code(s)	AX451, H5G1.1
Brand name	Soliris
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG2/4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	Complement C5
Indications of clinical studies	Membranous Nephritis, Rheumatoid Arthritis, Lupus, Psoriasis, Dermatomyositis
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, China, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	December 24, 1997
Start of Phase 2	August 15, 1999
Start of Phase 3
Date BLA/NDA submitted to FDA	September 15, 2006
Year of first approval (global)	2007
Date of first US approval	March 16, 2007
INN, US product name	Eculizumab
US or EU approved indications	Paroxysmal Nocturnal Hemoglobinuria, Myasthenia Gravis, Hemolytic Uremic Syndrome. Aug 2019: European Commission (EC) has approved the extension of the current marketing authorization of SOLIRIS® (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease. The U.S. Food and Drug Administration (FDA) approved SOLIRIS for the treatment of NMOSD in adult patients who are AQP4 antibody-positive on June 27, 2019.

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	AstraZeneca
Licensee/Partner	None
Comments about company or candidate	AstraZeneca acquired Alexion (formerly Syntimmune) in 2021.
Full address of company	Cambridge, United Kingdom Europe United Kingdom https://www.astrazeneca.com/our-company/contact-us.html