Idarucizumab Approved Naked monospecific

Antibody Information

Entry ID	34
INN	Idarucizumab
Status	Approved
Drug code(s)	BI 655075
Brand name	Praxbind
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Fragment
Format details	Fab
Isotype (Fc)	None
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	Dabigatran
Indications of clinical studies	Hemorrhage caused by anticoagulation effect of dabigatran
Primary therapeutic area	Cardiovascular / hemostasis 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)	September 15, 2012
Start of Phase 2
Start of Phase 3	May 15, 2014
Date BLA/NDA submitted to FDA	February 19, 2015
Year of first approval (global)	2015
Date of first US approval	October 16, 2015
INN, US product name	Idarucizumab
US or EU approved indications	Treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding

Company information

Company	Boehringer Ingelheim
Licensee/Partner	None
Comments about company or candidate	BLA filed in Feb 2015; priority review; approved in Oct 2015 under accelerated approval regulations, 21 CFR 601.41, which require further adequate and well-controlled clinical trials to verify and describe clinical benefit. Two Phase 1 studies as of Oct 2013; intravenous doses of up to 8 g are administered. Phase 3 in patients started in May 2014. Breakthrough therapy designation
Full address of company	Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany Europe Germany https://www.boehringer-ingelheim.com/contact-us

Description/comment

Intended to reduce dabigatran-induced anti-coagulation

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None