FDA Says No to New Cox-2 Inhibitor

WHITEHOUSE STATION, N.J., April 27 -- Merck said today that the FDA has rejected the investigational Cox-2 inhibitor etoricoxib (Arcoxia) for marketing.

Merck's announcement that it had received a non-approvable letter from the FDA was widely expected because just two weeks earlier an FDA advisory panel had overwhelmingly recommended that step.

The advisers voted 20 to 1 against recommending approval of the drug, declaring that the cardiovascular risks of etoricoxib outweighed its benefit for easing arthritis pain.

Panel member Richard Cannon, M.D., a cardiologist with the National Heart, Lung, and Blood Institute, said then that given the increased cardiovascular risk, 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 vote in favor of approval -- but even he qualified his approval of etoricoxib by saying that it should include a strict medical management program that would limit access to the drug.

Etoricoxib, which is approved in 63 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 after studies linked the drug to 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.