Alemtuzumab Approved Naked monospecific

Antibody Information

Entry ID	41
INN	Alemtuzumab
Status	Approved
Drug code(s)	CAMPATH-1H, LDP-03
Brand name	Lemtrada, Campath
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)	CD52
Indications of clinical studies	Multiple sclerosis, chronic lymphocytic leukemia
Primary therapeutic area	Cancer

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)	April 15, 1988
Start of Phase 2	September 15, 1992
Start of Phase 3
Date BLA/NDA submitted to FDA	December 23, 1999
Year of first approval (global)	2001
Date of first US approval	May 07, 2001
INN, US product name	Alemtuzumab
US or EU approved indications	Multiple sclerosis (treatment of patients with relapsing forms of multiple sclerosis)

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Millennium Pharmaceuticals Inc.
Licensee/Partner	None
Comments about company or candidate	First approved in 2001 for chronic myeloid leukemia; withdrawn for this indication and then approved in 2013 (EU) and 2014 (US) for multiple sclerosis
Full address of company	PO Box 616, Castle Hill, NSW 2154 Australia Australia https://www.milleniumpharma.com.au/contact