The U.S. Food and Drug Administration has announced its approval of Anthrasil, a drug intended to treat patients infected by inhalational anthrax.
The drug, officially Anthrax Immune Globulin Intravenous (Human), will be used in patient treatments in combination with currently used antibacterial drugs, the FDA says.
Anthrasil is designed to help anthrax victims even after they've begun displaying symptoms, a point that's normally too late for patients with the inhaled form of the infection.
Inhalational anthrax, a rare form of the disease, can follow exposure to infected animals or to contaminated animal products; it can also result from an intentional releasing of anthrax spores, the FDA notes.
Such an intentional release occurred in 2001, when five people died from inhaling anthrax spores sent through the mail in a bioterrorist attack. A scientist at a federal lab in Fort Detrick, Md., who was identified by the FBI as the main suspect committed suicide during the investigation.
In addition to using the drug against a potential bioterrorism attack, health officials say they want treatments like Anthrasil available in case of laboratory accidents.
Just such an incident in June 2014 in Atlanta potentially exposed government workers to live anthrax.
Inhalation of bacterial spores is considered one of the deadliest ways to contract the disease because it can take weeks after exposure for symptoms to present themselves, with a risk of massive and irreversible tissue injury and death.
"Today's approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in an FDA release. "This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency."
The new drug is made from blood plasma of individuals vaccinated against anthrax, plasma that contains antibodies that can neutralize the toxins produced by the anthrax bacteria.
In animal studies, conducted because it was neither feasible nor ethical to conduct safe, adequately controlled studies in humans, Anthrasil allowed at least some of the animals to survive what normally would be a lethal dose of aerosolized anthrax.
In one study using rabbits, Anthrasil and antibiotics in combination resulted in a 71 percent survival rate compared with a 25 percent survival rate in animals receiving antibiotics alone.
A Canadian company based in Winnepeg, Cangene Corp., developed Anthrasil under a $160 million contract from the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services.
