Obiltoxaximab Explained

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).^{[4] [5]}

The medication was developed by Elusys Therapeutics, Inc.^[6]

Medical uses

Obiltoxaximab is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis. 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.

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.

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.^[7]

In 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. It was approved for medical use in the European Union in November 2020.^[9]

External links

• Web site: Obiltoxaximab . U.S. National Library of Medicine . Drug Information Portal .

Notes and References

1. Web site: Summary Basis of Decision (SBD) for Anthim . Health Canada . 23 October 2014 . 29 May 2022.
2. Web site: Anthim- obiltoxaximab solution . DailyMed . 9 December 2019 . 21 September 2020.
3. Web site: Nyxthracis Product information . Union Register of medicinal products . 3 March 2023.
4. http://www.ama-assn.org/resources/doc/usan/x-pub/obiltoxaximab.pdf Statement On A Nonproprietary Name Adopted By The USAN Council - Obiltoxaximab
5. Hou AW, Morrill AM . Obiltoxaximab: Adding to the Treatment Arsenal for Bacillus anthracis Infection . The Annals of Pharmacotherapy . 51 . 10 . 908–913 . October 2017 . 28573869 . 10.1177/1060028017713029 . 39810240 .
6. Web site: Anthim (obiltoxaximab) Injection . U.S. Food and Drug Administration (FDA) . 26 April 2016 . 18 October 2020.
   • Web site: Center for Drug Evaluation and Research: Application Number: 125509Orig1s000: Summary Review . Food and Drug Administration.
7. Greig SL . Obiltoxaximab: First Global Approval . Drugs . 76 . 7 . 823–30 . May 2016 . 27085536 . 10.1007/s40265-016-0577-0 . 46099559 .
8. Web site: Obiltoxaximab SFL: Pending EC decision . European Medicines Agency (EMA) . 17 September 2020 . 21 September 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
9. Web site: Nyxthracis EPAR . European Medicines Agency (EMA) . 15 September 2020 . 27 November 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.