Lurie: Anthrax drug approval is major step forward
Lurie said that the U.S. Food and Drug Administration's approval of raxibacumab, an antibody approved for use with antibiotics to treat inhalational anthrax in children and adults, marks a major step forward in the nation's preparedness against bioterrorism. The drug is the first countermeasure developed and procured under Project BioShield to receive approval from the FDA.
Project BioShield has helped to develop more than a dozen products available under emergency use authorization. Raxibacumab is the first that will not need such authorization.
"Under Project BioShield, our Biomedical Advanced Research and Development Authority, has procured all of these drugs for the Strategic National Stockpile," Lurie said. "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."
While antibiotics can be used to treat people infected with anthrax, the antibiotics do not treat the effects of toxins produced by anthrax. Raxibacumab prevents the anthrax toxins from promoting harmful effects and increases the survival rate of people infected with anthrax.
Project BioShield partnered with Human Genome Sciences, which has since been acquired by GlaxoSmithKline, in 2005 to develop anthrax medical countermeasures.
"Our success rate shows Project BioShield is an effective tool in bringing our nation drugs we will need to protect health and save lives in an emergency," Lurie said.