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FDA approves new plague treatment

The FDA has approved levofloxacin for the treatment of plague — bubonic plague, pneumonic plague and septicemic plague — and to reduce the risk after exposure to Yersinia pestis, according to an FDA press release.

"Today's approval broadens the available therapeutic treatments for plague," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in a press release. "It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible."

While plague is rare and is mainly a disease found in animals, it can be spread to humans through bites from infected fleas, contact with infected animals or humans or exposure in the lab.

According to the release, the FDA approved levofloxacin (Levaquin, Janssen Pharmaceuticals) for plague under the agency's Animal Efficacy Rule. This rule allows adequate data from animal studies to when it is not feasible or ethical to conduct trials in humans.

FDA approval was based upon data from a study conducted in infected African green monkeys. Researchers randomly assigned monkeys to 10 days of levofloxacin (n=17) or placebo (n=7) within 6 hours of fever onset after infection. Primary outcome measure was overall survival. Ninety-four percent of monkeys treated with levofloxacin survived vs. none of the monkeys assigned placebo.

Levofloxacin has been added to other antibacterials in the tetracycline group as FDA-approved treatments for plague, including streptomycin, doxycycline and tetracycline.