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Botulism Antitoxin Wins FDA Approval

By Diane Barnes

Global Security Newswire

WASHINGTON -- The U.S. Food and Drug Administration has licensed the first drug for counteracting every form of a paralytic, food-borne toxin long feared as an attractive tool to would-be bioterrorists.

Botulinum toxin comes from a common form of bacteria and results in around 100 U.S. hospitalizations each year through tainted food and localized infections, according to a statement by Nicole Lurie, the Health and Human Services Department's assistant secretary for preparedness and response.

Governments developed botulinum toxin throughout the 20th century for use as an aerially dispersed bioweapon, and it is best suited for release in an enclosed area or for poisoning food supplies, the Centers for Disease Control and Prevention says. Seven forms of the substance cause irreversible nervous system damage and can make breathing impossible if left untreated, according to a fact sheet issued by the Center for Biosecurity at the University of Pittsburgh Medical Center. The toxin typically takes between 12 and 72 hours to produce visible signs when ingested, and its symptoms took roughly three days to become evident in the few recorded instances of inhalation.

"A biological terrorism event with botulinum nerve toxins would require a rapid health response with potentially little time to determine which botulism toxin was used," Lurie said in her released comments. "Because this new drug is approved to treat all known botulinum nerve toxin serotypes, the antitoxin can be used readily in this type of public health emergency."

The FDA license for Botulism Antitoxin Heptavalent was the second awarded to a drug prepared with support from Project Bioshield, a multibillion-dollar federal initiative to support development of WMD medical countermeasures. The agency licensed a Bioshield-supported anthrax treatment late last year and has authorized use of certain additional medicines in potential crises.

The Food and Drug Administration stated on Friday that licensing of the treatment followed efficacy trials involving 228 botulism victims as well as safety tests in 40 people who had not been exposed to the toxin.

The Canadian biotechnology firm Cangene is to deliver 200,000 doses of the drug to the U.S. Strategic National Stockpile of medical countermeasures under a 2006 agreement with Health and Human Services.

The firm in June 2011 said it had supplied 120,000 doses and intended to complete the remaining shipments by 2018. A Cangene representative on Monday declined to provide an update on deliveries.

The drug's development and acquisition contract is worth $427 million, an HHS spokeswoman told Global Security Newswire.

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