Assistant Secretary Nicole Lurie Statement on FDA Approval of First Anthrax Antitoxin Developed Under Project Bioshield

Targeted News Service

WASHINGTON, Dec. 14 — The U.S. Department of Health & Human Services issued the following news release:

With the U.S. Food and Drug Administration approval of the first drug for treatment of anthrax, our nation took a monumental step forward today in preparing for the health impacts of bioterrorism. Raxibacumab, manufactured by GlaxoSmithKline/Human Genome Sciences, is approved for use together with antibiotics to treat inhalational anthrax in both adults and children, and to prevent illness when alternative treatments are not available or appropriate. The drug is the first developed and procured under Project BioShield to receive FDA approval.

In 2001, only a few weeks after the terrorist attacks of Sept. 11, our nation was shocked and saddened as 11 people fell ill after inhaling anthrax bacteria sent through the mail. Five of them died from the anthrax infection.

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. 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.

Since 2005 we have partnered with Human Genome Sciences to develop and procure this product under Project Bioshield.

Using Project Bioshield, we have advanced the development of more than a dozen products which now can be made available under emergency use authorization, which means the FDA has determined that the product can be used in an emergency. Under Project Bioshield, our Biomedical Advanced Research and Development Authority, has procured all of these drugs 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 Project Bioshield is an effective tool in bringing our nation drugs we will need to protect health and save lives in an emergency.




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