Dr. Nicole Lurie, the assistant secretary for preparedness and response at the Department of Health and Human Services, has called the Food and Drug Administration’s (FDA) approval of raxibacumab, an antibody approved for use with antibiotics to treat inhalational anthrax in children and adults, “a major step forward in the nation’s preparedness against bioterrorism.”

The new drug, the first FDA-approved drug for anthrax treatment and the first countermeasure developed and procured under Project BioShield to receive approval from the FDA, prevents the anthrax toxins from promoting harmful effects and increases the survival rate of people infected with anthrax. Dr. Lurie said, “Under Project BioShield, our Biomedical Advanced Research and Development Authority, has procured all these drugs [more than a dozen products available under emergency use authorization] for the Strategic National Stockpile. The goal, however, is to have drugs that have completed the FDA approval process and therefore will not require FDA emergency authorization before they can be used. Today we have reached the goal with raxibacumab. Our success rate shows BioShield is an effective tool in bringing our nation drugs we will need to protect health and save lives in an emergency.”