Regulatory Focus™ > News Articles > FDA Close to Approving J&J Drug Via Animal Rule Pathway

FDA Close to Approving J&J Drug Via Animal Rule Pathway

Posted 05 April 2012 | By Alexander Gaffney, RAC 

Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Fierce Pharma.

The backing would involve the extremely rare use of an approval pathway known as the 'Animal Rule' pathway, which was created after a series of anthrax-based terror attacks in 2001 prompted FDA and other governmental officials to seek an approval pathway for drugs used to combat anthrax and other diseases.

In lieu of human clinical trials, companies can instead test drugs intended to treat highly dangerous or contagious conditions on human analogues such as monkeys or pigs.

Similar to the Animal Rule's intent, Levaquin is an antibiotic intended to treat pneumonic plague, and used data from nonclinical trials on monkeys to prove safety and efficacy.

"The government, not J&J, spearheaded the cause to study Levaquin for the new use nearly a decade ago and wants to stockpile the drug to make it immediately accessible in an emergency," explained Fierce Pharma-an unusual occurrence given that drug companies are usually the ones seeking approval.

Read more:

Fierce Pharma - 'Animal rule' allowed for J&J drug backed for new approval

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