Here’s what Bob Rappaport, director of the FDA’s of the anasthesia, analgesic and rheumatology products division, writes to the advisory committee that meets on Thursday to decide whether Merck’s Arcoxia - the Vioxx follow-up - should be recommended for approval:

“A new product that appears to have an increased overall profile risk for cardiovascular disease, particularly beyond that seen with other drugs in the class, would not be appropriate for marketing approval unless the product fills an unmet need for a particular patient populationt that has no relatively safer approved products to them, and provides a reasonable risk to benefit balance for that patient population.”

In other words, Merck has to convince this panel that Arcoxia is special. But the FDA staff that reviewed clinical studies didn’t exactly give the drug an outstanding grade. For instance, they noted that the risk of heart attacks and other cardiovascular problems by taking Arcoxia was similar to an older drug, diclofenac.

The FDA reviewers also said smaller and shorter studies showed Arcoxia appeared to carry greater cardiovascular risk than naproxen or a placebo, but less risk than other non-steroidal anti-inflammatory drugs (NSAIDs). And Arcoxia patients in a large safety study dropped out at a higher rate because of problems related to high blood pressure.

In its own separate summary, Merck argues that Arcoxia was less likely to cause gastrointestinal problems, such as bleeding, that can be complications from NSAIDs and its risks were “consistent” with other drugs in the class. The FDA says the rate of complicated GI problems, such as intestinal perforations, was about the same for Arcoxia and diclofenac

As Merrill Lynch’s Dave Risinger writes in an investor note this afternoon: “In our view, the decision for Arcoxia would essentially come down to whether the GI safety outweighs the renovascular risks.We don’t think it does, especially after (Pfizer’s) torcetrapib failure.”

Does any of this sound special?

One thing to watch: Of the panel’s 20 voting members, two have financial ties to Merck, although the FDA granted waivers despite new conflict-of-interest rules.

More in Reuters;
FDA staff briefing document;
Merck briefing document;
FDA panel members;
Integrity in Science Watch report.[tags]Arcoxia, Drug Safety, FDA, Merck, Vioxx[/tags]