Avelox is a quinolone antibiotic already approved for susceptible bacterial infections including acute sinusitis, acute exacerbations of chronic bronchitis, community acquired pneumonia, skin and skin structure, and complicated intra-abdominal infections.
The FDA approval for plague was based on an efficacy study conducted in African green monkeys that were infected with Yersinia pestis in a lab setting. The animals were randomized to receive a 10-day regimen of Avelox or placebo at least four hours after fever onset following exposure to Yersinia pestis. The ten monkeys treated with Avelox met the primary endpoint of survival. None of the ten monkeys treated with placebo survived.
Avelox was approved for plague under the Animal Efficacy Rule that allows efficacy data from adequate and well-controlled animal studies to be used in situations where it is not feasible or ethical to conduct human trials.
For more information visit FDA.gov.