The voting wasn’t even close: 20 to 1 urged the FDA not to approve Arcoxia for osteoarthritis. This is, obviously, a blow to Merck, but hardly surprising. The ‘Son of Vioxx,’ as some call Arcoxia, poses a similar cardiovascular risk as Vioxx, which of course was withdrawn due heart attacks and srokes.

The FDA staff, in its briefing documents, set a high hurdle: Arcoxia would have to offer an unmet need. But it didn’t. “There is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period,” says David Felson, an advisory committee member and a professor of medicine at Boston University.

During today’s meeting, FDA medical reviewer David Graham gave a stark warning: “What you’re talking about is a potential public health disaster. We could have a replay of what we had with” Vioxx.

The FDA isn’t obligated to follow the advice of its panels. But given the controversy over drug safety - which came into stark relief as a result of the Vioxx scandal - the FDA has come under enormous pressure to tread carefully when reviewing new drugs and, in particulary, side effects. For these reason, the betting is that the agency won’t approve Arcoxia.

Nonetheless, Merck’s chief scientist, Peter Kim, expressed obvious disappiontment, but isn’t going away quietly: “We are committed to continuing to work with the FDA to discuss the application in an effort to gain US regulatory approval for Arcoxia.”

Further reading:
Merck statement;
Bloomberg News.\;
The New York Times (registration required).[tags]Arcoxia, Merck, Vioxx[/tags]