FDA OKs Avelox to Treat Pneumonic, Septicemetic Plagues
The FDA has approved Bayer HealthCare’s Avelox for the treatment of pneumonic and septicemetic plague, under the animal efficacy rule. It also is approved to prevent plague in adults.
Avelox’s (moxifloxacin) approval was based on an efficacy study conducted in African green monkeys that were infected in a laboratory setting. All 10 monkeys treated with the drug survived while all of the monkeys treated with placebo died, the FDA says.
The animal efficacy rule allows efficacy findings from adequate and well-controlled animal studies to be used in cases where it’s not feasible or ethical to conduct human trials.
Avelox’s labeling includes a boxed warning that the drug increases the risk of tendon rupture and muscle weakness in people with myasthenia gravis.
Pneumonic plague infects the lungs, while septicemic plague infects the blood. Bubonic, the third common type of plague, affects the lymph nodes. The extremely rare disease strikes 1,000 to 2,000 victims worldwide each year. — John Bechtel