New Anthrax Treatment Anthrasil Approved By FDA

The U.S. Food and Drug Administration (FDA) has just approved Anthrasil (Anthrax Immune Globulin Intravenous) to help treat those who had previously inhaled anthrax in combination with other antibacterial drugs.

"To support the nation's preparedness against a possible anthrax attack, the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) purchased Anthrasil under Project BioShield in 2011 as an experimental drug for the U.S. Strategic National Stockpile," the FDA said in a statement.

According to health officials, the release of the inhaled toxin can result in massive tissue damage that may even result in serious injury or even death, in more severe issues.

To make the new treatment, they used the plasma from the individuals of those who had already been vaccinated against it, which contains potent antibodies to fight dangerous toxins that are produced by bacteria from the disease.

"Today's approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease," said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency."

The treatment was first used in animals to tests its safety and effectiveness on both rabbits and monkeys. They were exposed to lethal doses of anthrax spores when treated with both a placebo and the new drug.

Survival rate in monkeys was found to be between 36 and 70 percent when compared to none who received the placebo. For rabbits treated with the drug, survival rate was about 26 percent and only 2 percent in those who received the placebo.

Afterward, its safety was tested in 74 healthy human volunteers, with the most common side effects ranging from headache and back pain to nausea and infusion site pain.