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FDA Offers First License to Drug Produced by Bioshield Program

By Chris Schneidmiller

Global Security Newswire

WASHINGTON – The U.S. Food and Drug Administration on Friday issued a license for a new anthrax treatment, marking the first time the agency has approved a drug developed through the federal government’s controversial Project Bioshield program.

The U.S. Health and Human Services Department has since 2005 acquired an unspecified amount of Raxibacumab through the initiative aimed at promoting the production of bioterrorism antidotes.

The product is a protein that could be used to counter anthrax toxins that might otherwise cause “massive and irreversible tissue injury and death,” according to an FDA press release. It could be used alongside antibiotics to protect individuals exposed to the airborne release of the bacteria.

“Although antibiotics can be used effectively to treat people infected by anthrax, antibiotics do not treat the effects of the toxins produced by anthrax pathogens,” Nicole Lurie, assistant Health and Human Services secretary for preparedness and response, said in provided comments. “This newly approved drug prevents the harmful effects of anthrax toxins and thus raises the likelihood that people who become infected with anthrax will recover.”

Raxibacumab is also now the first “monoclonal antibody” to be authorized for use against inhalational anthrax and the first such countermeasure to receive FDA approval via the Animal Efficacy Rule, according to the department and manufacturer GlaxoSmithKline.

The rule allows the Food and Drug Administration to license drugs that have gone through extensive animal testing but cannot safely be proven to provide protection to humans against select diseases. In this case, the government could not expose human test subjects to anthrax.

The licensing announcement can be considered a win for Bioshield, which was established eight years ago with $5.6 billion intended to spur the biopharmaceutical sector to produce medical WMD countermeasures that might not find a large commercial market, said Amesh Adalja, a senior associate with the Center for Biosecurity at the University of Pittsburgh Medical Center.

The program has placed tens of millions of doses of drugs against anthrax and other unconventional threats into the Strategic National Stockpile. However, it has also seen high-profile failures, including cancellation of plans to acquire 75 million doses of a new anthrax vaccine. Health and Human Services Secretary Kathleen Sebelius and others have criticized the effectiveness and efficiency of the effort.

“I think it can be considered a success because really this is a drug that doesn’t have that big of a market in traditional markets,” Adalja told Global Security Newswire on Monday. “This is something that may not have been developed but for the market created by the government’s need to respond for things like anthrax.”

Raxibacumab is also essentially the first new countermeasure to anthrax developed since 2001, the year that five people died after exposure to spores delivered through the U.S. postal system, according to Adalja.

“Anything that has the capacity to decrease the morbidity and mortality from inhalational anthrax is going to be good,” he said.

The drug proved safe in human testing that did not involve exposure to anthrax, and protected at least 44 percent of animal test subjects faced with anthrax infection, the FDA release says. Using the antitoxin along with antibiotics increased the survival rate to 82 percent in another animal trial.

Licensing means the drug has been determined safe and effective and can be sold on the market. Previously, Raxibacumab would have required an FDA emergency use authorization to be used, agency spokeswoman Stephanie Yao stated by e-mail.

Health and Human Services said national security practices prevent it from divulging how many doses of the drug have been placed in the U.S. stockpile.

Roughly one dozen medical countermeasures produced under Bioshield could be used in an emergency, the department said. License requests for two additional anthrax treatments and a botulinum drug have been submitted, or are expected to be filed soon, with FDA approval for all sought no later than 2015.

Yao said federal law bars releasing the number of other Bioshield products that might be waiting for FDA licensing.

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