Raxibacumab is a

human Humans (''Homo sapiens'') or modern humans are the most common and widespread species of primate, and the last surviving species of the genus ''Homo''. They are Hominidae, great apes characterized by their Prehistory of nakedness and clothing ...

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

intended for the

prophylaxis Preventive healthcare, or prophylaxis, is the application of healthcare measures to prevent diseases.Hugh R. Leavell and E. Gurney Clark as "the science and art of preventing disease, prolonging life, and promoting physical and mental health a ...

and treatment of inhaled

anthrax Anthrax is an infection caused by the bacterium '' Bacillus anthracis'' or ''Bacillus cereus'' biovar ''anthracis''. Infection typically occurs by contact with the skin, inhalation, or intestinal absorption. Symptom onset occurs between one ...

. Its efficacy has been proven in rabbits and monkeys. In December 2012 raxibacumab was approved in the United States for the treatment of inhalational anthrax due to ''Bacillus anthracis'' in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The antibody was discovered in a joint venture between

Cambridge Antibody Technology Cambridge Antibody Technology Group Plc, (commonly referred to as CAT) was a biotechnology company headquartered in Cambridge, England. Its core focus was on antibody therapeutics, primarily using phage display, Phage Display and ribosome displ ...

and

Human Genome Sciences Human Genome Sciences (HGS) was a biopharmaceutical corporation founded in 1992 by Craig Venter, Alan Walton and Wally Steinberg. It uses the human DNA sequence to develop protein and antibody drugs. It had drugs under development to treat s ...

discovered the antibody to

's target and, in 2012, HGS was purchased by

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

(GSK). In 2017, CAT was acquired by

Emergent BioSolutions Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides m ...

Side effects

The most commonly observed adverse events are headaches, upper respiratory tract infection, nausea, pain in extremity and pruritus skin itching.

Pharmacology

Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis.

Development history

Raxibacumab was developed by Human Genome Sciences (HGS) in conjunction with the U.S. Department of Health and Human Services (HHS) under contract number HHS010020050006C. At the 2 November 2012 meeting of the Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) members "voted 16 to 1 in support of the clinical benefit of raxibacumab for the treatment of inhalational anthrax, with one abstention. In addition, the committee voted 18 – 0 in favour of the risk-benefit profile of raxibacumab". In 2009, support from the FDA was denied after it "expressed doubt on the agent's added benefit over the antibiotic levofloxacin (Levaquin) alone". On Dec. 14, 2012, FDA approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

References

Monoclonal antibodies Drugs developed by GSK plc {{antiinfective-drug-stub