|Target||Protective antigen of anthrax toxin|
|Drug class||Monoclonal antibody|
|Main uses||Treat and prevent inhaled anthrax|
|Side effects||Pain at the site of injection, headache, rash, itchiness, sleepiness|
|Chemical and physical data|
|Molar mass||142934.31 g·mol−1|
|(what is this?)|
Common side effects include pain at the site of injection, headache, rash, itchiness, and sleepiness. Other side effects may include anaphylaxis. It is a monoclonal antibody that binds to a part of the Bacillus anthracis toxin.
Raxibacumab was approved for medical use in the United States in 2012. In Europe it was given orphan designation in 2014. In the United States it can be acquired from the Strategic National Stockpile.
The most commonly observed adverse events are headaches, upper respiratory tract infection, nausea, pain in extremity and pruritus skin itching.
Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis.
The antibody was discovered in a joint venture between Cambridge Antibody Technology and Human Genome Sciences. Cambridge Antibody Technology discovered the antibody to Human Genome Sciences's target and, in 2012, HGS were purchased by GlaxoSmithKline (GSK). In 2017, it was acquired by Emergent BioSolutions.
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.
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- "UPDATE 2-FDA denies approval for Human Genome's anthrax drug". Reuters Market News. 16 November 2009.