FDA approves Levaquin for use against pneumonic plague
The FDA has authorized the use of the Johnson & Johnson-produced drug through the animal rule, which allows a medicine's approval to be based entirely on animal studies when it is not feasible to conduct clinical trials in humans, according to MedCityNews.com.
The U.S. regulator said that because plague is such a rare disease, adequate efficacy studies cannot be conducted in humans. Instead, Johnson & Johnson conducted studies on the African green monkey in a laboratory setting.
Levaquin can now be used to treat people with pneumonic plague and to reduce the risk posed to those that have been exposed to the bacteria that causes it.
The National Institute of Allergy and Infectious Diseases approached Janssen Pharmaceuticals, Johnson & Johnson's pharmaceutical arm, about obtaining approval for Levaquin nine years ago. The FDA's Anti-Infective Drugs Advisory Committee recommended the drug for accelerated approval at the beginning of April, MedCityNews.com reports.
The U.S. government has pushed for allowing Levaquin's use against the plague despite evidence that it can cause spontaneous tendon ruptures, especially in those above the age of 60. There are other drugs available for use against pneumonic plague but they are considered limited in effectiveness or supply.