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 |
|
| 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).[6][3][7]
The medication was developed by Elusys Therapeutics, Inc.[3][8]
Medical uses
Obiltoxaximab is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis.[3][4] 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.[3][4]
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.[9]
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.[10]
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.[11] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.[11] It was approved for medical use in the European Union in November 2020.[4]
References
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
- ^ "Summary Basis of Decision (SBD) for Anthim". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b c d e "Anthim- obiltoxaximab solution". DailyMed. 9 December 2019. Retrieved 21 September 2020.
- ^ a b c d "Nyxthracis EPAR". European Medicines Agency (EMA). 15 September 2020. Retrieved 27 November 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Nyxthracis Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Obiltoxaximab, American Medical Association.
- ^ Hou AW, Morrill AM (October 2017). "Obiltoxaximab: Adding to the Treatment Arsenal for Bacillus anthracis Infection". The Annals of Pharmacotherapy. 51 (10): 908–913. doi:10.1177/1060028017713029. PMID 28573869. S2CID 39810240.
- ^ "Anthim (obiltoxaximab) Injection". U.S. Food and Drug Administration (FDA). 26 April 2016. Retrieved 18 October 2020.
- "Center for Drug Evaluation and Research: Application Number: 125509Orig1s000: Summary Review" (PDF). Food and Drug Administration.
- ^ FDA Professional Drug Information
- ^ Greig SL (May 2016). "Obiltoxaximab: First Global Approval". Drugs. 76 (7): 823–30. doi:10.1007/s40265-016-0577-0. PMID 27085536. S2CID 46099559.
- ^ a b "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.
External links
- "Obiltoxaximab". Drug Information Portal. U.S. National Library of Medicine.
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