J&J plague treatment could gain fast FDA approval
A U.S. Food and Drug Administration Advisory panel recently agreed overwhelmingly that the biopharmaceutical's non-human primate studies provided ample evidence of the drug's efficacy in treating the plague. The panel voted similarly concerning Bayer's antibiotic Ciproflaxin, according to NJ.com.
William Foster, a spokesman for Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, said the FDA would most likely make a decision later this month. The FDA is not required to follow the advisory panel's recommendation, though it often does.
Ira Loss, a senior health care analyst at Washington Analysis, said the circumstances surrounding the Levaquin application are unusual.
"I don't know that they're going to profit from this," Loss said, NJ.com reports.
Federal health authorities have already include Levaquin in their stockpile of antibiotics, but have pushed for the drug's expanded approval in order to provide treatment more quickly in case of a plague outbreak, whether it occurs naturally or as a result of bioterrorism.
A nod from the FDA could lead to a temporary spike in sales for the product, but overall profits are expected to be minimized by the availability of generic versions.