Pharma

Bioterrorism threat spurs authorities to invoke animal rule for J&J antibiotic

The U.S. Food and Drug Administration, is reviewing whether to approve an expanded use of […]

The U.S. Food and Drug Administration, is reviewing whether to approve an expanded use of Johnson & Johnson‘s (NYSE: JNJ) antibiotic Levaquin to treat pneumonic plague, despite the fact that it’s only been tested on African green monkeys, amidst concerns the disease could be used in bioterrorism, according to a story published in the Star Ledger of New Jersey.

An FDA advisory panel this week agreed that studies using monkeys demonstrated Levaquin’s effectiveness in treating pneumonic plague. The FDA can invoke the animal rule, which allows evidence to support the approval to be based entirely on animal studies, to provide a regulatory pathway when human studies aren’t possible, the paper said.

The U.S. government has pushed for the use of Levaquin against the pneumonic plague, despite the fact that generic versions of the drug are available on the market. The National Institute of Allergy and Infectious Disease approached New Jersey-based Johnson & Johnson’s pharmaceutical arm Janssen Pharmaceuticals about getting approval for the drug as a treatment for pneumonic plague nine years ago, the Star Ledger said. Anthony Fauci, the director of the institute, told the paper it’s the first time the FDA’s animal rule has been invoked to get a drug approved to fight an infectious disease.

Levaquin has been approved to treat the effects of anthrax and is also approved for respiratory infections such as pneumonia and chronic along with urinary tract, kidney and prostate infections. It carries a black box warning, as do other powerful antibiotics designed to treat serious bacterial infections that are classified as fluoroquinolones. The warning includes a risk of spontaneous tendon rupture or tendonitis, particularly in people over 60 years old.

 

Shares0
Shares0