Raxibacumab

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Raxibacumab
Monoclonal antibody
Type Whole antibody
Source Human
Target Protective antigen of anthrax toxin
Clinical data
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
Chemical and physical data
Formula C6320H9794N1702O1998S42
Molar mass 142934.31 g·mol−1
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Raxibacumab [2] is a human monoclonal antibody intended for the prophylaxis and treatment of inhaled anthrax. Its efficacy has been proven in rabbits and monkeys. [3] 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. [4] [5]

Contents

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). [6] In 2017, it was acquired by Emergent BioSolutions [7]

Side effects

The most commonly observed adverse events are headaches, upper respiratory tract infection, nausea, pain in extremity and pruritus skin itching. [8]

Pharmacology

Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis. [8]

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. [8] 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". [8] In 2009, support from the FDA was denied after it "expressed doubt on the agent's added benefit over the antibiotic levofloxacin (Levaquin) alone". [9] 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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References

  1. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA . Retrieved 22 Oct 2023.
  2. ↑ Mazumdar S (2009). "Raxibacumab". mAbs. 1 (6): 531–8. doi:10.4161/mabs.1.6.10195. PMC   2791309 . PMID   20068396.
  3. ↑ Migone TS, Subramanian GM, Zhong J, Healey LM, Corey A, Devalaraja M, et al. (July 2009). "Raxibacumab for the treatment of inhalational anthrax". The New England Journal of Medicine. 361 (2): 135–44. doi: 10.1056/NEJMoa0810603 . PMID   19587338.
  4. ↑ "Approval Letter" (PDF). U.S. Food and Drug Administration.
  5. ↑ Kummerfeldt CE (2014). "Raxibacumab: potential role in the treatment of inhalational anthrax". Infection and Drug Resistance. 7: 101–9. doi: 10.2147/IDR.S47305 . PMC   4011807 . PMID   24812521.
  6. ↑ "GSK completes acquisition of Human Genome Sciences". GlaxoSmithKline. 3 August 2012. Archived from the original on 2013-10-04. Retrieved 2013-10-05.
  7. ↑ "Emergent BioSolutions Completes Acquisition of Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK". 3 October 2017.
  8. 1 2 3 4 "GSK announces FDA Advisory Committee vote in favour of raxibacumab for the treatment of inhalational anthrax infection". GlaxoSmithKline. 2 November 2012. Archived from the original on 2013-10-04. Retrieved 2013-10-05.
  9. ↑ "UPDATE 2-FDA denies approval for Human Genome's anthrax drug". Reuters Market News. 16 November 2009.


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