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Monkeys To Men: “Animal Rule” Study Of Cipro In Plague Gets Advisory Committee

 
• By Martin Berman-Gorvine

NIH studied the antibiotic known for its efficacy against anthrax as a treatment for pneumonic plague in African Green Monkeys because clinical trials cannot be conducted in human beings.

Whether a study using 12 African Green Monkeys infected with pneumonic plague provides sufficient evidence under the Animal Rule for the efficacy of ciprofloxacin (Bayer’s Cipro and generics) to treat the disease in human beings is the question before FDA’s Anti-Infective Drugs Advisory Committee April 3.

There is only one voting question for the day, in the afternoon session: “Does the evidence from the animal models evaluating ciprofloxacin predict response for treatment of humans with

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More from North America

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