Bezlotoxumab Approved Naked monospecific

Antibody Information

Entry ID	100
INN	Bezlotoxumab
Status	Approved
Drug code(s)	MDX-1388
Brand name	Zinplava
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 (GenPharm/Medarex/BMS transgenic mouse platform Ultimab)

Therapeutic information

Target(s)	C. difficile (enterotoxin B)
Indications of clinical studies	Clostridium Difficile Infection
Primary therapeutic area	Infectious diseases

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
Status	Active
Start of clinical phase (IND filing or first Phase 1)	December 15, 2005
Start of Phase 2
Start of Phase 3	October 15, 2011
Date BLA/NDA submitted to FDA	November 23, 2015
Year of first approval (global)	2016
Date of first US approval	October 21, 2016
INN, US product name	Bezlotoxumab
US or EU approved indications	Reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Bristol-Myers Squibb
Licensee/Partner	Merck
Comments about company or candidate	PDUFA date Oct 23 2016; priority review by FDA; Phase 3 studies of monotherapy or bezlotoxumab+actoxumab demonstrated that the combination did not provide added efficacy over bezlotoxumab alone
Full address of company	Route 206 & Province Line Road Princeton, New Jersey 08543 North America United States of America https://www.bms.com/about-us/contact-us.html