FDA advisory panel votes against Merck & Co.'s Arcoxia by Alison Fischer

April 12, 2007
FDA advisory panel votes against Merck & Co.'s Arcoxia by Alison Fischer
An FDA advisory committee voted 20-1 against recommending approval for Merck & Co.'s Arcoxia (etoricoxib) over safety concerns.
Clinical data have suggested that the drug may increase the risk of cardiovascular adverse events, and panel member David Felson noted that "there is nothing special about this drug that would warrant giving it to patients and putting them at risk of a cardiovascular death, period." Committee member Richard Cannon added that "we don't have strong data that there is a need for this drug, compared to what's already available."
At the meeting, FDA drug safety expert David Graham told panel members that Arcoxia "probably confers a substantial increase in cardiovascular risk." Graham also stated that "what you're talking about is a potential health disaster. We could have a replay of what we had with [Vioxx]."
In response, Peter Kim, president of Merck Research Laboratories, commented that the company is "disappointed" with the committee's decision. "We continue to believe that Arcoxia has the potential to become a valuable treatment option for [patients] suffering from osteoarthritis." The drugmaker, which is seeking approval to sell the product in the US as a treatment for the signs and symptoms of the disease, plans to continue to discuss its application with the FDA. An agency decision about whether to approve the compound is expected by the end of the month.
Arcoxia, which is approved in more than 60 countries outside the US, had revenue of $265 million in 2006.