Johnson & Johnson's Doribax squeaked through an FDA advisory panel yesterday, winning its blessing as an effective treatment for hospital-acquired pneumonia on a 7-6 vote. And at least one panelist still had doubts: "I voted yes with great reservation," Dr. James K. Stoller told Dow Jones, citing worries about J&J's supporting studies.
Like FDA staffers, a majority of the expert panelists weren't happy with the studies J&J used as justification for the antibiotic's new use. They voted 9-4 against accepting those trials, saying they weren't statistically rigorous enough to prove Doribax works as well as older drugs for the same use. FDA reviewers said they'd found cases in which "patients with worsening chest X-rays were evaluated as cures." And some panelists thought the drugmaker should have produced evidence that Doribax saved as least as many lives as existing meds. But an AstraZeneca VP on the panel didn't like that idea at all, saying that "practical compromises" are necessary to get new drugs onto the market.
But ultimately, enough of the panels weighed in on the positive side of the ledger to get Doribax its recommendation. The FDA doesn't have to follow that advice, but it usually does. If it rejects Doribax's new indication, analysts said, that could create a high bar for other hospital-acquired pneumonia drugs to clear.