YAbS







Alirocumab Approved Naked monospecific

Antibody Information

Entry ID 124
INN Alirocumab
Status Approved
Drug code(s) REGN727, SAR236553
Brand name Praluent
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 (Velocimmune)

Therapeutic information

Target(s) PCSK9
Indications of clinical studies High cholesterol
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) October 15, 2009
Start of Phase 2
Start of Phase 3 July 15, 2012
Date BLA/NDA submitted to FDA November 24, 2014
Year of first approval (global) 2015
Date of first US approval July 24, 2015
INN, US product name Alirocumab
US or EU approved indications High cholesterol (treatment of adults with high low-density lipoprotein (LDL) cholesterol); reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

Company information

Company Regeneron Pharmaceuticals
Licensee/Partner None
Comments about company or candidate None
Full address of company Tarrytown, New York, United States
North America
United States of America
https://www.regeneron.com/

Description/comment

Lowers low-density lipoprotein (LDL) cholesterol by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) levels

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None