Doribax

FDA won't expand Doribax use now

Tracy Staton — Fri, 22 Aug 2008 10:56:06 -0400

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. 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
- see the Health Blog's take
- check out the coverage in Forbes

Panel gives mixed blessing to J&J's Doribax

Tracy Staton — Thu, 17 Jul 2008 10:14:13 -0400

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.

- see J&J's release
- read the story in Forbes
- check out the Dow Jones coverage

Related Articles:
FDA extends Doribax review
Doribax--2007 FDA approvals

J&J's consumer sales drive earnings growth

Tracy Staton — Tue, 15 Jul 2008 10:29:48 -0400

Mixed news on Johnson & Johnson today, too: Reporting its second-quarter results this morning, J&J announced a healthy 8 percent hike in net income on strong sales of its consumer products. The company also boosted its 2008 earnings forecast (for the second time) to $4.50 per share from $4.45. But that good news follows an FDA announcement late yesterday that it has "major concerns" about the company's application for a new indication on its antibiotic Doribax.

Let's look at the earnings first. Profits came in at $3.33 billion, up from $3.08 billion year-over-year; revenues rose 8.7 percent to $16.45 billion. EPS of $1.17 per share handily beat Wall Street estimates of $1.12. It was consumer products, though, that delivered the goods. Newly over-the-counter Zyrtec helped boost those sales by 13.2 percent. But pharma sales themselves only grew by 3.1 percent. The autoimmune drug Remicade saw its sales expand by 2 percent, which, though modest, certainly outclassed Procrit, the anemia drug, which fell by 14 percent. Sales of the antipsychotic Risperdal dropped 16 percent in advance of a quarter's-end generic competitor; we'll have to wait and see how that drug fares with full-on generic competition next quarter.

On Doribax, the FDA had been entertaining the antibiotic as a treatment for ventilator patients with pneumonia. Currently, the drug is OK'd for complicated urinary tract and intra-abdominal infections. The agency said that many patients in the study lacked convincing evidence that they had pneumonia. So, FDA says, it can't properly evaluate the efficacy of the drug for this use. The indication is up for discussion at an FDA advisory panel later this week, so we'll soon see what those experts think.

- read J&J's earnings release
- see the Wall Street Journal's earnings coverage
- find the WSJ's story on Doribax
- check out CNN Money's Doribax article