- The FDA approves Bayer HealthCare Pharmaceuticals' (OTCPK:BAYRY +4.1%) Avelox (moxifloxacin) for the treatment and prevention of plague, a rare and potentially fatal bacterial infection affecting only 1K to 2K people worldwide each year. The three most common types are bubonic, pneumonic and septicemic.
- The agency approved Avelox under its "animal rule" which allows licensure based on well-controlled animal studies because it was not feasible or ethical to conduct human placebo-controlled trials. The data supporting clearance was based on a study in African green monkeys that were infected with the Yersinia pestis bacterium in a laboratory setting. Animals were randomly selected to receive a 10-day regimen of Avelox or placebo at least four hours after the onset of fever following exposure to Y. pestis. The primary endpoint was survival. All 10 monkeys treated with Avelox survived versus none of the 10 who received placebo.