J&J Antibiotic Approved Via 'Animal Rule' Pathway
| Posted: 30 April 2012
By Alexander Gaffney
After being backed by a US Food and Drug Administration (FDA) advisory committee, life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic intended to treat pneumonic plague.
The drug’s approval is notable because it utilizes a rarely-used approval pathway known as the ‘Animal Rule’ pathway. The pathway allows sponsors of products intended to treat very dangerous or contagious conditions to forgo clinical trials and instead test the products on human analogues such as monkeys or pigs.
“The FDA approved Levaquin for plague after tests on African green monkeys infected with the bacteria in a lab found 94% of the monkeys given Levaquin survived,” reports The Associated Press.
None of the animals given a placebo survived, noted Med Page Today.
Levaquin is manufactured by J&J subsidiary Jenssen Pharmaceuticals.
Med Page Today - Levaquin OK'd to Treat Plague
PharmaPro - FDA Approves Antibiotic to Treat, Prevent Plague
Med City News - FDA approves Levaquin to combat pneumonic plague bioterrorist attack
Regulatory Focus - FDA Close to Approving J&J Drug Via Animal Rule Pathway