The U.S. Food and Drug Administration on Friday approved Levaquin, an antibiotic made by Johnson & Johnson (JNJ) unit Janssen Pharmaceuticals Inc., for treatment of the now-rare plague.
The agency also approved the drug to reduce the risk of contracting the
plague after exposure to Yersinia pestis, the bacterium that causes the disease.
The bug, despite its devastating track record before the advent of modern
medicine, is now extremely rare in most parts of the world. There are about
1,000 to 2,000 cases each year.
Plague is a mainly animal disease that humans can contract from fleas, other
animals or laboratory exposure. The disease could also be used as a bioterrorism
agent, the FDA said.
The FDA based its approval on an efficacy study on African green monkeys
because it isn't feasible or ethical to conduct trials on humans.
The agency granted Levaquin a priority review. It joins streptomycin,
doxycycline, tetracycline and other antibacterial drugs among the FDA-approved
treatments for plague.
J&J shares were recently up 22 cents at $64.97 Friday. The stock is off
0.9% this year.