Raxibacumab

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Raxibacumab ?
Monoclonal antibody
Type Whole antibody
Source Human
Target Protective antigen of anthrax toxin
Clinical data
Legal status ?
Identifiers
CAS number 565451-13-0 N
ATC code J06BB18
Chemical data
Formula C6320H9794N1702O1998S42 
Mol. mass 142.93 kDa
 N (what is this?)  (verify)

Raxibacumab [1] is a human monoclonal antibody intended for the prophylaxis and treatment of inhaled anthrax. Its efficacy has been proven in rabbits and monkeys.[2] In December 2012 raxibacumab was approved 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.Approval Letter

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.[3]

According to GSK "Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis and is being developed for the treatment of inhalational anthrax. The most commonly observed adverse events were headaches, upper respiratory tract infection, nausea, pain in extremity (pain in limbs) and pruritus (skin itching). Local skin reaction in one study has led to the recommendation that an anti-histamine be administered prior to infusion."[4]

GSK go on to say "Raxibacumab was developed by Human Genome Sciences (HGS) in conjunction with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS) under contract number HHS010020050006C. It is now part of GSK’s portfolio, following GSK’s acquisition of HGS in July 2012. The development of raxibacumab is the result of a coordinated response to a recognised public health threat and the US government’s request for new medical countermeasures in the event of an anthrax attack against the civilian population."[5]

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".[6]

In 2009, support from the FDA was denied after it "expressed doubt on the agent's added benefit over the antibiotic levofloxacin (Levaquin) alone".[7]

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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