FDA: The U.S. Food and Drug Administration today approved Avelox
(moxifloxacin) to treat patients with plague, a rare and potentially
fatal bacterial infection. The agency approval for plague includes use
of the drug for the treatment of pneumonic plague (infection of the
lungs), and septicemic plague (infection of the blood). Avelox is also
approved 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. The three most common
forms of plague are bubonic plague (infection of the lymph nodes),
pneumonic plague and septicemic plague.
“Today’s approval provides
an additional therapy for the treatment of plague,” said Edward Cox,
M.D., M.P.H, director of the Office of Antimicrobial Products in the
FDA’s Center for Drug Evaluation and Research.
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.
The 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 such a rare disease, it
would not be possible to conduct adequate efficacy trials in humans.
Avelox’s
approval was based on an efficacy study conducted in African green
monkeys that were infected with Yersinia pestis in a laboratory setting.
Animals were randomly selected to receive a 10-day regimen of Avelox or
placebo at least four hours after the onset of fever following exposure
to Yersinia pestis. The primary endpoint was survival at the end of the
study. All 10 monkeys treated with Avelox survived. None of the 10
monkeys treated with placebo survived.
Avelox’s safety has been
characterized in clinical studies and post-marketing information for the
drug’s existing clinical uses. Common side effects are nausea,
diarrhea, headache and dizziness.
Avelox carries a Boxed Warning
regarding an increased risk of tendinitis and tendon rupture and
worsening of muscle weakness in people with the neuromuscular disorder
myasthenia gravis. Other side effects include allergic reactions, liver
damage, abnormalities of the blood, effects on the nervous system and
abnormal heart rhythm. However, given that plague is a very serious and
often deadly condition, the benefit of Avelox for treating plague
outweighs these potential risks. Avelox is manufactured by Whippany, New
Jersey-based Bayer HealthCare Pharmaceuticals.
The FDA, an agency
within the U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness, and security of
human and veterinary drugs, vaccines and other biological products for
human use, and medical devices. The agency also is responsible for the
safety and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.