FDA won't expand Doribax use now

The FDA hasn't exactly said "no" to Johnson & Johnson's Doribax, but it has definitely said "not yet." J&J had asked the agency to expand the use of the IV antibiotic to hospital-acquired pneumonia; right now, it's only approved for serious abdominal and urinary tract infections. But the FDA said it needs more info before it makes a decision.

As you know, an advisory committee voted narrowly in favor of the new use for Doribax [1]. But lately, the FDA has been going against its expert advice, as the Wall Street Journal Health Blog notes. It rejected Schering-Plough's sugammedex in spite of a unanimous approval rec. And it delayed a decision on J&J's psoriasis med, ustekinumab. That was another unanimous vote in favor.

In Doribax's case, FDA staff had expressed some doubts about the data J&J submitted in support of its pneumonia use, calling the info "flawed." The advisory committee, despite voting in favor of the new indication, questioned the design of the pneumonia trial. J&J hasn't said just what additional info the agency has asked for, and neither has the FDA; we'll have to wait and see whether the agency wants a whole new trial.

- read J&J's press release
[2]- see the Health Blog's take [3]
- check out the coverage [4] in Forbes

Related Articles:
J&J's consumer sales drive earnings growth [5]
FDA Advisory Committee Provides Opinion of DORIBAX(TM) [6]
FDA extends Doribax review [7]
Doribax--2007 FDA approvals [8]