FDA panel recommends against Vioxx successor
By Andrew Bridges
Associated Press
WASHINGTON — A pain-killer proposed as a successor to Vioxx should not be approved, a panel of federal health advisers overwhelmingly recommended yesterday.
The nonbinding 20-1 vote was on the prescription drug Arcoxia, made by Merck & Co. Inc.
A Food and Drug Administration drug safety expert had told the panel the drug may increase substantially the risk of stroke and heart attack and is no more effective for pain relief than other medicines in the same class.
"What you're talking about is a potential public health disaster," Dr. David Graham told the outside experts before the vote. Graham was a leading critic of Vioxx, a related drug also known as rofecoxib.
"We could have a replay of what we had with rofecoxib," Graham said.
Merck is seeking the FDA's approval to sell Arcoxia, also known as etoricoxib, to treat the signs and symptoms of osteoarthritis. Merck, based in Whitehouse Station, N.J., withdrew Vioxx in 2004 after the drug was linked to a higher risk of stroke and heart attack when compared with dummy pills.
The FDA is not required to follow the recommendations of its advisory committees, but the agency usually does. Merck expects the FDA will make a final decision by April 27.
"Merck's disappointed. We continue to believe Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis," company spokeswoman Kyra Lindemann said.
Panel member Dr. Richard Cannon said the decision came down to whether patients needed another nonsteroidal anti-inflammatory drug, or NSAID. There are about 20 drugs in this class and they are common treatments for osteoarthritis, which affects an estimated 21 million people in the United States.
"We don't have strong data that there is a need for this drug, compared to what's already available," said Cannon, a cardiologist with the National Heart, Lung and Blood Institute.
Fellow panelist Dr. James Fries, a Stanford University rheumatologist, called it a "weak argument" that there was a "crying need" for more treatment options.
"We continue to believe the overall risk-to-benefit profile is favorable to support approval of Arcoxia," Dr. Scott Korn, executive director of regulatory affairs for Merck's research laboratories, said after the meeting.
Merck has compiled more long-term safety data for the experimental drug than for any other NSAID, said Peter Kim, president of Merck's research laboratories.
Arcoxia and Vioxx are types of NSAIDs called Cox-2 inhibitors, developed to be gentler on the stomach.
The FDA said this week that new NSAIDs that increase the risk of stroke and heart attack should not win approval if safer alternatives are available.
"The idea should not be we need new drugs. The idea should be we need better drugs," said Martha Solonche, the advisory panel's patient representative.