ObiltoxaximabMonoclonal antibody

Type| Whole antibody
Source| Chimeric (mouse/human)
Target| Bacillus anthracis anthrax
Names
Trade names| Anthim, Obiltoxaximab SFL
Other names| ETI-204
Clinical data
Drug class| Monoclonal antibody[1]
Main uses| Treat and prevent anthrax[1]
Side effects| Headache, 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 dose| 16 to 32 mg/kg[1]
External links
AHFS/Drugs.com| Monograph
Legal
License data|

* US DailyMed: Obiltoxaximab

Legal status|

* US: ℞-only [2]
* EU: Rx-only

Chemical and physical data
Formula| C6444H9994N1734O2022S44
Molar mass| 145521.59 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]

## Contents

* 1 Medical uses
* 1.1 Dosage
* 2 History
* 3 Society and culture
* 3.1 Legal status
* 4 References
* 5 External links

## Medical uses[edit | edit source]

### Dosage[edit | edit source]

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[edit | edit source]

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

## Society and culture[edit | edit source]

### Legal status[edit | edit source]

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[edit | edit source]

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. Archived from the original on 16 July 2017. Retrieved 6 November 2021.
2. ↑ 2.0 2.1 "Anthim- obiltoxaximab solution". DailyMed. 9 December 2019. Archived from the original on 30 November 2020. Retrieved 21 September 2020.
3. ↑ 3.0 3.1 "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. ↑ 8.0 8.1 "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.

## External links[edit | edit source]

External sites:|

* US NLM: Obiltoxaximab

|

Identifiers:|

* ATC code:

* J06BB22 (WHO)

* CAS Number: 1351337-07-9
* DrugBank:

* DB05336

* ChemSpider:

* none

* UNII:

* 29Z5DNL48C

* KEGG:

* D10776 Y

* v
* t
* e

Monoclonal antibodies for infectious disease and toxins

Fungal|

| Human|

* Efungumab†

|

Viral|

| Human|

* Ansuvimab
* Atoltivimab (+maftivimab/odesivimab)
* Avdoralimab§
* Bamlanivimab† (+etesevimab)†
* Bebtelovimab§
* Casirivimab† (+imdevimab)
* Cilgavimab† (+tixagevimab)†
* Diridavumab§
* Etesevimab†
* Exbivirumab§
* Foravirumab§
* Imdevimab† (+casirivimab)
* Libivirumab§
* Maftivimab
* Nirsevimab†
* Odesivimab
* Rafivirumab§
* Regavirumab§
* Regdanvimab
* Sevirumab†
* Sotrovimab
* Suptavumab
* Tixagevimab† (+cilgavimab)†
* Tuvirumab§

|

Chimeric|

* Cosfroviximab
* Larcaviximab
* Porgaviximab

Humanized|

* Felvizumab§
* Lenvervimab†
* Motavizumab†
* Palivizumab
* Suvizumab§

Bacterial|

| Human|

* Nebacumab
* Panobacumab§
* Raxibacumab

|

Mouse|

* Edobacomab§

Chimeric|

* Pagibaximab†

Humanized|

* Tefibazumab†

Toxin|

| Human|

* Actoxumab§
* Bezlotoxumab
* Suvratoxumab

|

Chimeric|

* Obiltoxaximab

Humanized|

* Urtoxazumab§

* #WHO-EM
* ‡Withdrawn from market
* Clinical trials:
* †Phase III
* §Never to phase III

*[US]: United States
*[EU]: European Union
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