FDA Advisers Give Overwhelming Rejection to Etoricoxib (Arcoxia)

GAITHERSBURG, Md., April 12 -- By a vote 20 to one, FDA advisers recommended today against approval of Merck's Cox-2 inhibitor etoricoxib (Arcoxia).

The FDA's Arthritis Drugs Advisory Committee declared that the cardiovascular risks of the drug outweigh its benefits for easing arthritis pain.

Richard Cannon, M.D., a National Heart, Lung, and Blood Institute cardiologist, and a member of the committee, said he was convinced there was a cardiovascular risk with the drug "and it comes down to determining whether there is a clinical need for this drug."

In the final analysis, Dr. Cannon said, Merck failed to convince him and other panel members that "there's a need for this drug in addition to what's already available."

P. Jay Pasricha, M.D., of the University of Texas Medical Branch at Galveston, cast the only yea vote for the drug, but he even he qualified his approval by saying that it should include a strict medical management program that would limit access to the drug.

The FDA usually follows recommendations of its advisory committees, but it is not required to do so.

At a press conference following the vote, Robert Meyer, M.D., M.P.H. of the FDA's Center for Drug Evaluation and Research, said he came away with the opinion that the advisory committee intended its vote to resonate beyond etoricoxib.

The message, Dr. Meyer said, is that the FDA should no longer approve "just another product in a class if it has the same level of risk as existing products and does not offer a unique benefit."

Merck provided data that suggested etoricoxib had a cardiovascular safety profile that was comparable to diclofenac, an old NSAID that is rarely used in the United States. Other studies have suggested that among NSAIDs diclofenac has the worst cardiovascular risk.

Arcoxia, which is already approved in 48 countries for treatment of arthritis pain, was the first Cox-2 inhibitor to come before the FDA since Merck voluntarily withdrew rofecoxib (Vioxx) from the market in September 2004. Merck acted after studies linked the drug to an increased risk of cardiovascular events.

The following spring Pfizer withdrew valdecoxib (Bextra) after similar reports surfaced about it. The FDA then ordered boxed warnings about cardiovascular risks added to the labels of all non-steroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin.