The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

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. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.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. Because Anthrasil was not approved, its use prior to today’s approval would have required an emergency use authorization from the FDA.

Anthrasil is manufactured from the plasma of individuals vaccinated against anthrax. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439752.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery