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FDA approves Anthim for inhalation anthrax
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The FDA recently approved Anthim for the treatment and, when alternative therapies are not available, prevention of inhalational anthrax, according to a press release.
Inhalational anthrax disease occurs after exposure to infected animals or contaminated animal products, or from an intentional release of Bacillus anthracis spores. Once inhaled, the bacteria replicate and produce toxins that may result in irreversible tissue injury and death. Anthrax may be used as a potential bioterrorism weapon as the spores can be released into the air and cannot be destroyed, according to the FDA.
Edward Cox
“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
The monoclonal antibody Anthim (obiltoxaximab; Elusys Therapeutics) neutralizes toxins produced by B. anthracis. It was approved under the FDA’s Animal Rule, which allows the use of data from animal efficacy trials when human efficacy trials are not ethical or feasible. Animals treated with obiltoxaximab had a higher survival rate compared with animals treated with placebo, the release said. Survival rates increased when obiltoxaximab was administered in combination with antibacterial drugs.
The safety of obiltoxaximab was assessed in 320 healthy human volunteers. The most common adverse events included headache, itching, upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site. The new treatment carries a boxed warning alerting health care providers of the risk for hypersensitivity, including anaphylaxis.
“Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis,” the release said. “However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to outweigh this risk.”
Disclosure: Cox reports no relevant financial disclosures.
Perspective
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Edward A. Bell, PharmD, BCPS
The recent approval of Anthim (obiltoxaximab) adds to the armamentarium of pharmacologic agents we can use to treat inhalational anthrax. Anthrax is a potential bioterrorism tool, as the spores of this gram-positive bacterial pathogen are highly stable in the environment and can enter the respiratory tract, resulting in high morbidity and mortality. Anthrax may also result from human contact with infected animals or animal products. As the global geopolitical climate rapidly changes and worsens, bioterrorism unfortunately seems a distinct possibility.
Anthim is a monoclonal antibody directed towards the protective antigen of Bacillus anthracis, preventing the intracellular entry and release of its lethal and edema toxins. Another monoclonal antibody, raxibacumab (GlaxoSmithKline), was approved in 2012 for the treatment of inhalational anthrax due to Bacillus anthracis; with the addition of Anthim, both of these monoclonal antibodies are now labeled for use in combination with appropriate antibiotics. It is certainly hoped that there is little or no need for these biologic drugs, although their availability provides some degree of comfort.
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