Obiltoxaximab: First Global Approval
| Autor: | Sarah L. Greig |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Inhalation anthrax medicine.medical_specialty Obiltoxaximab Bacterial Toxins 030106 microbiology Pharmacology Anthrax 03 medical and health sciences Pharmacotherapy medicine Animals Humans Pharmacology (medical) Intensive care medicine Drug Approval Respiratory Tract Infections Antigens Bacterial Clinical Trials Phase I as Topic biology business.industry Antibodies Monoclonal biology.organism_classification United States Bacillus anthracis Phase i study Clinical trial Macaca fascicularis 030104 developmental biology Protective antigen Inhalational anthrax Antitoxins Rabbits business |
| Zdroj: | Drugs. 76:823-830 |
| ISSN: | 1179-1950 0012-6667 |
| DOI: | 10.1007/s40265-016-0577-0 |
| Popis: | Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. |
| Databáze: | OpenAIRE |
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