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]
In March 2016, obiltoxaximab was approved by the U.S. Food and Drug Administration (FDA) for the treatment and prophylaxis of inhalational anthrax.[9]
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.[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]
1234"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.
↑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. PMID28573869. S2CID39810240.
12"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 copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
External links
"Obiltoxaximab". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on May 24, 2021.