Evolocumab Approved Naked monospecific

Antibody Information

Entry ID	17
INN	Evolocumab
Status	Approved
Drug code(s)	AMG 145
Brand name	Repatha
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG2
Light chain isotype	lambda
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse (Xenomouse)

Therapeutic information

Target(s)	PCSK9
Indications of clinical studies	Hypercholesterolemia and High Risk for Cardiovascular Events, homozygous familial hypercholesterolemia
Primary therapeutic area	Metabolic 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)	July 01, 2009
Start of Phase 2
Start of Phase 3	January 15, 2012
Date BLA/NDA submitted to FDA	August 27, 2014
Year of first approval (global)	2015
Date of first US approval	August 27, 2015
INN, US product name	Evolocumab
US or EU approved indications	High cholesterol. REPATHA is indicated: to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease; as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C); as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Amgen
Licensee/Partner	Astellas
Comments about company or candidate	Partnership with Astellas for marketing in Japan. Approved in EU on July 22, 2015; approved in US on Aug 27, 2015
Full address of company	Thousand Oaks, California, United States North America United States of America https://www.amgen.com/