The Food and Drug Administration has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax, in combination with appropriate antibacterial drugs.
Anthim is a monoclonal antibody that neutralizes toxins produced by the bacterium Bacillus anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
The drug was developed by Elusys Therapeutics Inc. of Pine Brook, N.J., in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.
Anthim’s effectiveness was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived, compared with animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.
The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.
For more information, see the FDA’s approval announcement .
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