Raxibacumab

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Raxibacumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetProtective antigen of anthrax toxin
Clinical data
Drug classMonoclonal antibody[1]
Main usesTreat and prevent inhaled anthrax[2]
Side effectsPain at the site of injection, headache, rash, itchiness, sleepiness[2]
External links
AHFS/Drugs.comMonograph
US NLMRaxibacumab
Chemical and physical data
FormulaC6320H9794N1702O1998S42
Molar mass142934.31 g·mol−1
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Raxibacumab is a medication used to treat and prevent inhaled anthrax.[2] It is generally used together with antibiotics.[2] It is given by gradual injection into a vein.[1]

Common side effects include pain at the site of injection, headache, rash, itchiness, and sleepiness.[2] Other side effects may include anaphylaxis.[2] It is a monoclonal antibody that binds to a part of the Bacillus anthracis toxin.[1]

Raxibacumab was approved for medical use in the United States in 2012.[2] In Europe it was given orphan designation in 2014.[3] In the United States it can be acquired from the Strategic National Stockpile.[4]

Medical use

It is used to treat and prevent inhaled anthrax.[2] Its efficacy has been proven in rabbits and monkeys.[5]

Dosage

In those over 40 kg it is given at a dose of 40 mg/kg.[2] In those between 10 and 40 kg a dose of 60 mg/kg is used.[2]

Side effects

The most commonly observed adverse events are headaches, upper respiratory tract infection, nausea, pain in extremity and pruritus skin itching.[6]

Pharmacology

Raxibacumab injection is a monoclonal antibody targeting the protective antigen (PA) component of the lethal toxin of Bacillus anthracis.[6]

History

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

  1. 1.0 1.1 1.2 "Raxibacumab Monograph for Professionals". Drugs.com. Retrieved 16 October 2021.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 "DailyMed - RAXIBACUMAB injection". dailymed.nlm.nih.gov. Retrieved 16 October 2021.
  3. "EU/3/14/1352: Orphan designation for the treatment of inhalation anthrax disease". Retrieved 16 October 2021.
  4. Bower, William A. (0019). "Use of Anthrax Vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019". MMWR. Recommendations and Reports. 68. doi:10.15585/mmwr.rr6804a1. ISSN 1057-5987. Retrieved 16 October 2021.
  5. 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.
  6. 6.0 6.1 6.2 "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.
  7. "GSK completes acquisition of Human Genome Sciences". GlaxoSmithKline. 3 August 2012. Archived from the original on 2013-10-04. Retrieved 2013-10-05.
  8. "Emergent BioSolutions Completes Acquisition of Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK". 3 October 2017.
  9. "UPDATE 2-FDA denies approval for Human Genome's anthrax drug". Reuters Market News. 16 November 2009.

External links

Mazumdar S (2009). "Raxibacumab". mAbs. 1 (6): 531–8. doi:10.4161/mabs.1.6.10195. PMC 2791309. PMID 20068396.

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