The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s (NYSE: JNJ) antibiotic Levaquin against pneumonic plague in the event of a bioterrorist attack through its rarely invoked animal rule, according to a statement from the U.S. regulator.
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. Because plague is such a rare disease, it would not be possible to conduct adequate efficacy trials in humans, the FDA statement said.
Levaquin’s approval was based on an efficacy study conducted in African green monkeys that were infected with the plague bacterium in a laboratory setting.
The expanded use allows Leviquin to be used to treat people with the pneumonic plague and to reduce the risk of people exposed to the bacterium that causes the disease. Pneumonic plague is an infection of the lungs likened to a malignant form of pneumonia that has a high death rate unless those infected with the bacteria get immediate treatment.
The National Institute of Allergy and Infectious Disease approached New Brunswick, New Jersey-based Johnson & Johnson’s pharmaceutical arm Janssen Pharmaceuticals about getting approval for the drug to treat pneumonic plague nine years ago.
The FDA’s Anti-Infective Drugs Advisory Committee recommended the accelerated approval at the start of April.
The U.S. government has pushed for the use of Levaquin against the pneumonic plague, despite a black box warning that accompanies it and other strong antibiotics of its potential to cause spontaneous tendon ruptures, with adults over 60 years old particularly at risk. Although there are other drugs available to treat the pneumonic plague, evidence for the efficacy of tetracyclines is limited and there are limited supplies of streptomycin because it is is infrequently used in the U.S., according to committee documents.
