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Web Date: April 17, 2007

No To Arcoxia

FDA panel sees no advantage to COX-2 inhibitor, cites potential heart damage
Department: Government & Policy

A Food & Drug Administration advisory panel last week recommended that Arcoxia, Merck's successor to the recalled Vioxx, not be approved for sale in the U.S. In a vote of 20 to 1, the panel said they see no advantage to Arcoxia over other drugs on the market.

FDA also expressed concern that Arcoxia, or etoricoxib, an osteoarthritis treatment that belongs to a class called nonsteroidal anti-inflammatory drugs (NSAIDs), could damage the heart.

Merck, which presented results of several clinical safety trials in support of the drug, argues that Arcoxia is as safe as other pain relievers. "We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis," said Peter S. Kim, president of Merck Research Laboratories.

Panel members were critical of Merck's decision to compare Arcoxia in one large study with diclofenac, a drug that is not widely used in the U.S. and is regarded as more of a threat to the heart than naproxen, which they said would be a more appropriate drug to compare with Arcoxia.

Robert J. Myer, director of the FDA Office of Drug Evaluation II, told reporters at a press conference after the panel's meeting that the panel's concerns may extend to other NSAIDs, "with the possible exception of naproxen."

Merck removed Vioxx from the market in 2004 in light of studies showing it doubled the risk of heart attack and stroke. Both Vioxx and Arcoxia are types of COX-2 enzyme inhibitors. The company, which filed a New Drug Application for Arcoxia with FDA in 2003, expected a final decision on the drug later this month, but the panel's near-unanimous vote against its approval indicates that Arcoxia is unlikely to be commercialized in the U.S.

Merck says it will continue selling the drug in other countries.

 
Chemical & Engineering News
ISSN 0009-2347
Copyright © American Chemical Society

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