The U.S. Food and Drug Administration approved antibacterial agent Levaquin, to treat people with the pneumonic plague and to reduce the risk of people exposed to the bacterium that causes the disease, according to a statement from the U.S. regulator.
The antibiotic, generically called levofloxacin, is already approved for a range of indications, got the nod under the FDA's Animal Efficacy Rule.
The animal efficacy rule allows evidence to support a drug's approval to be based entirely on animal studies to provide a regulatory pathway in instances where it is not feasible or ethical to conduct trials in humans. Plague is a rare disease, with only 1,000 and 2,000 cases a year around the world, and hence would not be possible to conduct adequate efficacy trials in humans, the FDA statement said. The regulators approved Levaquin for plague after tests on African green monkeys infected with Yersinia pestis in a lab found 94 percent of the monkeys given Levaquin survived.
Levaquin is produced by Janssen Pharmaceuticals, a unit of Johnson & Johnson (JNJ).
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