Chemistry:Obiltoxaximab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | Bacillus anthracis anthrax |
| Clinical data | |
| Trade names | Anthim, Nyxthracis, others |
| Other names | ETI-204 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6444H9994N1734O2022S44 |
| Molar mass | 145521.59 g·mol−1 |
Obiltoxaximab, sold under the brand name Anthim among others, is a monoclonal antibody medication designed for the treatment of exposure to Bacillus anthracis spores (etiologic agent of anthrax).[5][2][6]
The medication was developed by Elusys Therapeutics, Inc.[2][7]
Medical uses
Obiltoxaximab is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis.[2][3] It is also indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available.[2][3]
Adverse effects
The most frequently reported adverse reactions were headache, pruritus, upper respiratory tract infections, cough, urticaria, nasal congestion, pain in extremity, and injection site reactions such as bruising at site of IV placement, infusion site swelling and infusion site pain.[8]
Society and culture
Legal status
In March 2016, obiltoxaximab was approved by the U.S. Food and Drug Administration (FDA) for the treatment and prophylaxis of inhalational anthrax.[9]
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.[10] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.[10] It was approved for medical use in the European Union in November 2020.[3]
References
- ↑ "Summary Basis of Decision (SBD) for Anthim". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00516&lang=en.
- ↑ 2.0 2.1 2.2 2.3 2.4 "Anthim- obiltoxaximab solution". 9 December 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39ad8799-00a4-4fc8-9852-c0536350c474.
- ↑ 3.0 3.1 3.2 3.3 "Nyxthracis EPAR". 15 September 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/nyxthracis-previously-obiltoxaximab-sfl. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Nyxthracis Product information". https://ec.europa.eu/health/documents/community-register/html/h1485.htm.
- ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Obiltoxaximab, American Medical Association.
- ↑ "Obiltoxaximab: Adding to the Treatment Arsenal for Bacillus anthracis Infection". The Annals of Pharmacotherapy 51 (10): 908–913. October 2017. doi:10.1177/1060028017713029. PMID 28573869.
- ↑ "Anthim (obiltoxaximab) Injection". 26 April 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000TOC.cfm.
- ↑ FDA Professional Drug Information
- ↑ "Obiltoxaximab: First Global Approval". Drugs 76 (7): 823–30. May 2016. doi:10.1007/s40265-016-0577-0. PMID 27085536.
- ↑ 10.0 10.1 "Obiltoxaximab SFL: Pending EC decision". 17 September 2020. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/obiltoxaximab-sfl. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
External links
- "Obiltoxaximab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/obiltoxaximab.
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