Raxibacumab Approved for Inhalational Anthrax
FRIDAY, Dec. 14 -- Raxibacumab injection has been approved by the United States Food and Drug Administration to treat inhalational anthrax, an infectious disease caused by breathing in deadly anthrax spores, the agency said Friday.
Raxibacumab neutralizes the toxins produced by the anthrax bacterium Bacillus anthracis. This infection can cause "massive and irreversible tissue injury and death," the FDA said in a news release.
Raxibacumab is a monoclonal antibody, acting like a human antibody that attacks foreign bacteria and viruses.
Anthrax, the FDA said, "is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air."
"In addition to antibiotics, raxibacumab will be a useful treatment to have available should an anthrax bioterrorism event occur," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in the news release. "Although antibiotics are approved to prevent and treat anthrax infection, raxibacumab is the first approved agent that acts by neutralizing the toxins produced by B. anthracis."
Raxibacumab's effectiveness was evaluated in monkeys and rabbits. Between 44 percent and 64 percent of the animals survived exposure to anthrax after being treated with raxibacumab, compared to none that survived anthrax exposure in an untreated control group.
Raxibacumab was developed by Human Genome Sciences, based in Rockville, Md.
Posted: December 2012