Raxibacumab Approved Naked monospecific

Antibody Information

Entry ID	6
INN	Raxibacumab
Status	Approved
Drug code(s)	Abthrax
Brand name	None
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	lambda
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Phage display (CAT library)

Therapeutic information

Target(s)	B. anthracis (PA)
Indications of clinical studies	Anthrax 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 US
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 22, 2003
Start of Phase 2
Start of Phase 3	March 15, 2008
Date BLA/NDA submitted to FDA	May 14, 2009
Year of first approval (global)	2012
Date of first US approval	December 14, 2012
INN, US product name	Raxibacumab
US or EU approved indications	Anthrax (treatment of inhalational anthrax; prevention of inhalational anthrax when alternative therapies are not available or not appropriate)

Company information

Company	GlaxoSmithKline
Licensee/Partner	Emergent Biosolutions
Comments about company or candidate	US orphan; Fast track. July 2017: GlaxoSmithKline granted Emergent BioSolutions rights to regulatory approvals and intellectual property rights for its FDA-approved anthrax monoclonal antibody raxibacumab. Under the terms of the deal, GSK will get a $76 million upfront payment and up to $20 million for sales and milestone payments 'GlaxoSmithKline acquired Human Genome Sciences in 2012. Fast track designation in Aug 2003; orphan drug designation in Nov 2003. IND filed May 22, 2003 [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125349Orig1s000MedR.pdf; p.13)
Full address of company	980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None