'Animal rule' allowed for J&J drug backed for new approval
Johnson & Johnson ($JNJ) has entered some atypical regulatory terrain. FDA advisors have heartily backed approval for the drug giant's antibiotic Levaquin for a new use that the federal government had pushed for. And experts were willing to vote for the drug to hit the market for that use based on monkey studies, using the so-called "animal rule."
It turns out that Levaquin, one of the mighty fluoroquinolone antibiotics, has shown an ability to combat pneumonic plague--which is a potentially lethal disease that the government worries could be used in an act of bioterrorism. The antibiotic has been used for a long time to treat various bugs, and the FDA is expected to decide whether to issue an approval for its use against pneumonic plague later this month, The New Jersey Star-Ledger reported.
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. According to the Star-Ledger report, J&J might see a temporary jump in sales of the antibiotic if the FDA grants the approval, yet the increase might be short-lived because of generic drug competition.
Drug companies, not the U.S. government, are usually the ones seeking additional approvals for drugs as a way to maximize sales of meds after they are given initial market green light from regulators. While animal data might help a company get a nod to begin clinical trials, safety and efficacy data from human studies are typically demanded for these and nearly all other market approvals.
J&J's Levaquin didn't need human evidence for the panel's endorsement, but the company also doesn't appear to be in line for any major profit gains from this potential approval of the antibiotic.
- read the Star-Ledger's article