Pharma Blog Watch
Not Likely to Approve Arcoxia (Pharmalot)
In his blog, Ed Silverman discusses an FDA advisory committee's recommendation against approval of Merck's Arcoxia. "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 The 'Son of Vioxx,' as some call Arcoxia, poses a similar cardiovascular risk as Vioxx, which of course was withdrawn due heart attacks and strokes."
"The FDA isn't obligated to follow the advice of its panels," he writes. "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 particular, side effects. For these reasons, the betting is that the agency won't approve Arcoxia."