Obiltoxaximab

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

    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 2 3 4 5 6 7 8 9 10 11 12 13 "Obiltoxaximab Monograph for Professionals". Drugs.com. Archived from the original on 16 July 2017. Retrieved 6 November 2021.
    2. 1 2 "Anthim- obiltoxaximab solution". DailyMed. 9 December 2019. Archived from the original on 30 November 2020. Retrieved 21 September 2020.
    3. 1 2 "Obiltoxaximab SFL". Archived from the original on 7 December 2020. Retrieved 6 November 2021.
    4. ↑ "Obiltoxaximab". SPS - Specialist Pharmacy Service. 11 November 2020. Archived from the original on 23 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. Archived from the original on 7 November 2021. Retrieved 6 November 2021.
    6. ↑ "Anthim (obiltoxaximab) Injection". U.S. Food and Drug Administration (FDA). 26 April 2016. Archived from the original on 19 October 2020. Retrieved 18 October 2020. Lay summary (PDF). {{cite web}}: Cite uses deprecated parameter |lay-url= (help)
    7. ↑ Greig SL (May 2016). "Obiltoxaximab: First Global Approval". Drugs. 76 (7): 823–30. doi:10.1007/s40265-016-0577-0. PMID 27085536.
    8. 1 2 "Obiltoxaximab SFL: Pending EC decision". European Medicines Agency (EMA). 17 September 2020. Archived from the original on 23 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. Archived from the original on 7 December 2020. Retrieved 27 November 2020.
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