FDA Approves Plague Treatment

Avelox can be used to treat patients with pneumonic plague (infection of the lungs) or septicemic plague (infection of the blood).

The U.S. Food and Drug Administration on May 8 approved Avelox (moxifloxacin) to treat patients with plague, which is a rare and potentially fatal bacterial infection. The approval allows the drug to be used to treat patients with pneumonic plague (infection of the lungs) and septicemic plague (infection of the blood) and also for prevention of plague in adult patients.

Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year, according to FDA, which noted the three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague, and septicemic plague.

"Plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. The bacteria that causes plague, Yersinia pestis, is considered a biological threat agent that could potentially be used as a bioterrorism agent," according to the agency.

FDA approved Avelox for plague under the agency's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to be used in cases where it is not feasible or ethical to conduct trials in humans. Because plague is so rare, it would not be possible to conduct adequate efficacy trials in human beings, according to FDA.

Avelox is manufactured by Whippany, N.J.-based Bayer HealthCare Pharmaceuticals.

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