Obiltoxaximab

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Obiltoxaximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetBacillus anthracis anthrax
Names
Trade namesAnthim, Obiltoxaximab SFL
Other namesETI-204
Clinical data
Drug classMonoclonal antibody[1]
Main usesTreat and prevent anthrax[1]
Side effectsHeadache, itchiness, upper respiratory tract infection, pain at the site of injection[1]
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
use
Intravenous
Typical dose16 to 32 mg/kg[1]
External links
AHFS/Drugs.comMonograph
US NLMObiltoxaximab
Legal
License data
Legal status
Chemical and physical data
FormulaC6444H9994N1734O2022S44
Molar mass145521.59 g·mol−1

Obiltoxaximab, sold under the brand name Anthim, is a medication used to treat and prevent anthrax.[1] It is used together with antibiotics for cases affecting the lungs.[1] It is given by gradual injection into a vein.[3]

Common side effects include headache, itchiness, upper respiratory tract infection, and pain at the site of injection.[1] Other side effects may include anaphylaxis.[1] While there has not be found to be harm in pregnancy, such use has not been well studied.[1] It is a monoclonal antibody which binds to the Bacillus anthracis toxin.[1]

Obiltoxaximab was approved for medical use in the United States in 2016 and Europe in 2020.[1][3] While approved in the United Kingdom and Europe, it is not available their as of 2021.[4] In the United States it is kept in the Strategic National Stockpile.[5]

Medical uses

Dosage

It is used at a dose of 16 to 32 mg/kg.[1] The dose in those over 40 kg is 16 mg/kg well that in those under 15 kg is 32 mg/kg.[1]

History

It was developed by Elusys Therapeutics, Inc.[2][6]

Society and culture

Legal status

In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment and prophylaxis of inhalational anthrax.[7]

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for obiltoxaximab, intended for the treatment or post-exposure prophylaxis of inhalational anthrax.[8] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.[8] It was approved for medical use in the European Union in November 2020.[9]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 "Obiltoxaximab Monograph for Professionals". Drugs.com. Retrieved 6 November 2021.
  2. 2.0 2.1 "Anthim- obiltoxaximab solution". DailyMed. 9 December 2019. Retrieved 21 September 2020.
  3. 3.0 3.1 "Obiltoxaximab SFL". Retrieved 6 November 2021.
  4. "Obiltoxaximab". SPS - Specialist Pharmacy Service. 11 November 2020. Retrieved 6 November 2021.
  5. "BRIEF-Elusys Therapeutics Awarded $25.2 Mln Delivery Order By U.S. Govt. For Anthim (Obiltoxaximab)". Reuters. 23 April 2018. Retrieved 6 November 2021.
  6. "Anthim (obiltoxaximab) Injection". U.S. Food and Drug Administration (FDA). 26 April 2016. Retrieved 18 October 2020. Lay summary (PDF).
  7. Greig SL (May 2016). "Obiltoxaximab: First Global Approval". Drugs. 76 (7): 823–30. doi:10.1007/s40265-016-0577-0. PMID 27085536.
  8. 8.0 8.1 "Obiltoxaximab SFL: Pending EC decision". European Medicines Agency (EMA). 17 September 2020. Retrieved 21 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. "Obiltoxaximab EPAR". European Medicines Agency (EMA). 15 September 2020. Retrieved 27 November 2020.

External links

External sites:
Identifiers: