FDA panel could give Bayer painkiller an edge over rivals from Pfizer, J&J

What if every drug in a class posed a risk to the heart--all except one? That's the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world.

An FDA panel of outside experts will meet this week to weigh the evidence on this group of drugs, which includes ibuprofen, sold by Johnson & Johnson ($JNJ) under the brand name Motrin, as well as in generic form. It also includes Celebrex, a prescription painkiller sold by Pfizer ($PFE), and Pfizer's version of ibuprofen, Advil. For years, since another NSAID--the notorious Vioxx--was pulled off the market, these drugs have worn a warning about cardiovascular risks associated with them. The FDA experts are considering whether that warning is still necessary for all of these drugs.

And it's possible that the panel will remove the warning on Bayer's brand Aleve (naproxen), and Aleve alone. That would give the drug an edge over its peers--an edge that would no doubt show up in a television commercial soon after.

As The Wall Street Journal notes, FDA review staff concluded that Aleve does indeed lack the cardiovascular risks of ibuprofen and Celebrex. After reviewing an analysis of 700 studies of the drugs, epidemiologist Andrew Mosholder wrote that Aleve's label "should be amended to reflect the more favorable cardiovascular risk profile of naproxen."

None of those studies pitted the drugs against one another in a single trial. There is, however, such a trial going on right now at the Cleveland Clinic, and data are expected next year. And here's where the plot thickens: Apparently, some at the FDA question whether that trial should continue, given the difference in risks that's already apparent from Mosholder's look at those 700 studies.

The Cleveland Clinic, meanwhile, says that its study is focusing on high-risk cardiac patients. Because "events"--adverse outcomes such as heart attack, stroke and hospitalization--are naturally most common in high-risk patients, the study could help differentiate the drugs very clearly. Plus, it's a very large study, with 20,000 patients involved, which would lend more weight to the findings.

The doctors participating in this study are among those who will testify before the FDA's advisory panel Monday and Tuesday. The companies themselves will make their cases. As the WSJ reports, Pfizer thinks the trial should continue and existing labeling remain in force. J&J also supports the existing labeling. Bayer, for its part, tells the Journal that Aleve is safe and that it presents little to no cardiovascular risk.

At the end of all that the FDA will be looking to its expert advisers for, well, advice. After the panel vote, the agency could adopt that advice; it usually does follow its advisory committees' recommendations, but not always. Stay tuned.

- read the WSJ story (sub. req.)

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