Obiltoxaximab
| Monoclonal 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 |
|
| Routes of use | Intravenous |
| Typical dose | 16 to 32 mg/kg[1] |
| External links | |
| AHFS/Drugs.com | Monograph |
| Legal | |
| License data | |
| Legal status | |
| 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]
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
- ↑ 1.00 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. Archived 16 July 2017 at the Wayback Machine
- ↑ 2.0 2.1 "Anthim- obiltoxaximab solution". DailyMed. 9 December 2019. Archived from the original on 30 November 2020. Retrieved 21 September 2020. Archived 30 November 2020 at the Wayback Machine
- ↑ 3.0 3.1 "Obiltoxaximab SFL". Archived from the original on 7 December 2020. Retrieved 6 November 2021. Archived 7 December 2020 at the Wayback Machine
- ↑ "Obiltoxaximab". SPS - Specialist Pharmacy Service. 11 November 2020. Archived from the original on 23 November 2020. Retrieved 6 November 2021. Archived 23 November 2020 at the Wayback Machine
- ↑ "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. Archived 7 November 2021 at the Wayback Machine
- ↑ "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. Archived 19 October 2020 at the Wayback Machine
- Lay summary in: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000SumR.pdf.
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- Lay summary in: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000SumR.pdf.
- ↑ Greig SL (May 2016). "Obiltoxaximab: First Global Approval". Drugs. 76 (7): 823–30. doi:10.1007/s40265-016-0577-0. PMID 27085536.
- ↑ 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. Archived 23 September 2020 at the Wayback Machine Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Obiltoxaximab EPAR". European Medicines Agency (EMA). 15 September 2020. Archived from the original on 7 December 2020. Retrieved 27 November 2020. Archived 7 December 2020 at the Wayback Machine
External links
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| Identifiers: |
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