Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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) |
| Target(s) | B. anthracis (PA) |
| Indications of clinical studies | Anthrax infection |
| Primary therapeutic area | Infectious diseases |
| 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 | 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/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |