April 30, 2012
FDA Approval Gives Us A Chance To Fight Bioterrorism, Plague
The FDA has announced its approval of the antibacterial agent levofloxacin, or “Levaquin,” to treat and prevent the plague. Manufactured by Johnson & Johnson, Levaquin was approved under the FDA´s Animal Efficacy rule which allows results from animal testing to be studied if such tests on humans aren´t ethical or feasible. Why prevent the plague, and why now?
Also known as Yersinia pestis, the plague is considered to be a bioterrorism threat. As such, the US government approached Johnson & Johnson and asked them to seek the new approval from the FDA, according to the Newark Star-Ledger.A strong antibiotic, Levaquin was developed to treat respiratory infections. In order to determine its ability to ward off the pneumonic plague, the drug was tested on animals. After studying the test results, an advisory panel recommended the FDA approve the drug to be used as a treatment for the plague.
Though Johnson & Johnson already has approval for Levaquin to be used to treat respiratory infections, it is not uncommon for US pharma to seek multiple approvals from the FDA. This practice allows the drug makers to sell the same drug under different names, squeezing as much profit as they can from one drug. Though such an approval could mean a brief spike in sales, a senior health care analyst from Washington Analysis doubts Johnson & Johnson stand to make much more money from this additional approval.
“I don´t know that they´re going to profit from this,” said Ira Loss, according to the Star-Ledger.
Levaquin has already been stockpiled by the US government in the event of a bioterrorism attack. According to federal health authorities, this new FDA approval will help them provide treatment more quickly, should the need arise.
This isn´t the first time Levaquin has been considered a viable treatment option for the plague. The National Institute of Allergy and Infectious Diseases (NIAID) first asked Johnson & Johnson to study Levaquin as an option to treat the plague back in 2003. Since its first arrival on the market in 1996, Levaquin has also been approved to treat bladder infections and the effects of Anthrax, also once considered to be a bioterrorism threat. As the drug is taken orally and has a two-year shelf life, Levaquin is well suited to be used in national stockpiles.
Director of the NIAID Anthony Fauci said Levaquin has already been shown to be effective in treating the plague, but this new approval allows the government to begin stockpiling it as such. Otherwise, the government would have to seek emergency approval should the need suddenly arise.
“We wanted to get around the situation of having to evoke an emergency authorization," he said, “but using the animal rule is a little different than developing a new drug."
To study Levaquin´s effectiveness at fighting off the effects of the plague, Army researchers studied African green monkeys, a move which, according to Fauci, is somewhat rare.
“It´s an important recommendation. It´s the first recommendation for approval using the animal rule for an infectious disease," Fauci said.