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]
| 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 |
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| UNII | |
| Chemical and physical data | |
| Formula | C6320H9794N1702O1998S42 |
| Molar mass | 142934.31 g·mol−1 |
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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 was purchased by GlaxoSmithKline (GSK).[6] In 2017, CAT was acquired by Emergent BioSolutions[7]
Side effects
editThe most commonly observed adverse events are headaches, upper respiratory tract infection, nausea, pain in extremity and pruritus skin itching.[8]
Pharmacology
editRaxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis.[8]
Development history
editRaxibacumab 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.
References
edit- ^ "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.
- ^ Mazumdar S (2009). "Raxibacumab". mAbs. 1 (6): 531–8. doi:10.4161/mabs.1.6.10195. PMC 2791309. PMID 20068396.
- ^ 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.
- ^ "Approval Letter" (PDF). U.S. Food and Drug Administration.
- ^ 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.
- ^ "GSK completes acquisition of Human Genome Sciences". GlaxoSmithKline. 3 August 2012. Archived from the original on 2013-10-04. Retrieved 2013-10-05.
- ^ "Emergent BioSolutions Completes Acquisition of Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK". 3 October 2017.
- ^ a b c d "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.
- ^ "UPDATE 2-FDA denies approval for Human Genome's anthrax drug". Reuters Market News. 16 November 2009.
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