“We are disappointed with today’s decision,” says a glum Peter Kim, Merck’s chief scientist. “We pursued FDA approval of Arcoxia because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies.”
Disappointed, yes. But is anyone surprised?
The Merck statement.[tags]Arcoxia, Merck[/tags]

As a follow-up to the basic headline that an FDA panel nixed Merck’s Arcoxia, here are the impressions of one watchdog who attended the proceedings. Merrill Goozner, who runs the Integrity in Science Watch project for the Center for Science in the Public Interest in Washington, DC, had this to say:
“After listening to the company’s [...]

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 The ‘Son of Vioxx,’ as some call Arcoxia, poses a similar cardiovascular risk as Vioxx, which of course was withdrawn due heart attacks and srokes.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 [...]

David Graham, FDA medcal reviewer, urges rejection:
Arcoxia “probably confers a substantial increase in cardiovascular risk. What you’re talking about is a potential public health disaster. We could have a replay of what we had with” Vioxx.
Peter Kim, Merck’s chief scientist, pleads for approval:
“We at Merck believe (Arcoxia) represents a valuable treatment option for patients with [...]

So much for the FDA’s new conflict-of-interest guidelines.
The FDA is giving the thumbs up to three scientists, including two with financial ties to Merck, to serve on the April 12 athritis drugs advisory panel that will review Arcoxia. The follow-up drug to Vioxx is controversial because some leading experts are critical of studies showing a [...]

Two in two days. What are we talking about? Yesterday, the FDA convinces Valeant Pharmaceuticals to withdraw Permax, a drug for Parkinson’s, along with two generic versions. Today, Novartis is yanking the Zelnorm irritable bowel syndrome, which may reduce painful gas but also holds out the possibility of causing a heart attack. Not a good [...]

This will be one very interesting - and possibly highly charged - meeting the agency’s Arthritis advisory committee will hold to determine whether the painkiller should be approved.
Not only will the stakes be high for Merck, which desperately needs a new drug in its arsenal, the FDA’s credibility will be on the line. This will [...]

You don’t expect the drugmaker to quit, do you?
Of course not. The latest effort is published in The Lancet, and the Merck-funded study finds the incidence of upper gastrointestinal events in patients on Arcoxia was less than in those folks taking diclofenac. The authors reached their conclusion after analyzing the so-called MEDAL trials. (You can [...]

Pfizer’s Ian Read is predictably bullish about prospects for the maligned NSAID. He just told Wall Streeters at the big briefing that cardiovascular safety is being discussed with doctors “front and center,” ahead of efficacy.
He then crowed that the approach appears to be working, based on early data showing new prescriptions written, although he didn’t [...]