FDA has approved moxifloxacin (Avelox) for the treatment of patients with plague. Avelox has been approved under the Animal Efficacy Rule, because it was not ethical to conduct human trials.
FDA has approved moxifloxacin (Avelox, Bayer Healthcare) for the treatment of patients with plague.
Plague is an extremely rare and potentially fatal bacterial infection caused by the bacteria, Yersinia pestis, which is considered a biological threat agent. It can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. The 3 most common forms of plague are bubonic plague, pneumonic plague and septicemic plague, according to FDA.
Avelox is a broad-spectrum fluoroquinolone antibiotic that acts by inhibiting DNA gyrase and topoisomerase IV, enzymes responsible for separating bacterial DNA. Through inhibition of these enzymes, bacterial cell replication is halted. Avelox was previously approved for other bacterial infections, including acute sinusitis, exacerbations of chronic bronchitis, skin and skin structure infections, and complicated intra-abdominal infections.
The FDA approved Avelox for the treatment of plague under the Animal Efficacy Rule, which allows efficacy finding from adequate and well-controlled animal studies to be used in cases where it is not feasible or ethical to conduct human trials. Avelox’s approval was based on an efficacy study conducted in African green monkeys infected with Yersinia pestis that were randomly assigned to receive either a 10-day regimen of Avelox or placebo. All of the monkeys treated with Avelox lived, while none of the monkeys treated with placebo survived.
FDA's approval includes use of Avelox for the treatment of pneumonic plague, infection of the lungs, and septicemic plague, infection of the blood. The drug also is approved for the prevention of plague in adults.
Common side effects associated with Avelox in clinical studies and post-marketing information include nausea, diarrhea, headache and dizziness. Avelox also carries a Boxed Warning for the increased risk of tendinitis, tendon rupture, and worsening of muscle weakness in people with myasthenia gravis.