FDA approves new anthrax treatment
pharmafile | March 22, 2016 | News story | Manufacturing and Production, Research and Development | Antibacterial, FDA, US, anthim, anthrax, defense, inhalational
The US Food and Drug Administration (FDA) has approved Anthim (obiltoxaximab) to treat inhalational anthrax in combination with appropriate antibacterial drugs, or in isolation when alternative therapies are not available or not appropriate.
Developed by Elusys Therapeutics, Anthim is a monoclonal antibody that binds to the protective antigen component of anthrax toxin. Its neutralising activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death.
As the severity of anthrax means that it isn’t feasible or ethical to conduct controlled clinical trials in humans with inhalational anthrax, the efficacy of Anthim is based on efficacy studies in two animal models. The drug was developed in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH) and the Department of Defense (DoD).
Elizabeth Posilico, president and chief executive officer of American-based Elusys, comments: “This marks a historic milestone for our company, resulting from unprecedented partnership with several government agencies, to develop a new anthrax antitoxin that will be an important addition to the Strategic National Stockpile (SNS) and help protect the safety of our citizens and emergency personnel in the event of bio warfare attack.”
Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, adds: “As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax.”
Sean Murray
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