FDA advisory committee votes against recommending approval of Arcoxia for treating OA

Panelists were wary of recommending a potentially harmful drug, particularly due to uncertainty over whether the market needs another selective COX-2 inhibitor.

The FDA's Arthritis Advisory Committee voted 20-1 yesterday against recommending approval of Merck's osteoarthritis drug Arcoxia. This is the first marketing application for a COX-2 inhibitor to be reviewed by the FDA since the withdrawal of Vioxx in 2004.

The panel acknowledged the efficacy of Arcoxia (etoricoxib) for treating osteoarthritis (OA), but said there was insufficient proof that it was more effective than products already on the market, and it may increase the risk of stroke and cardiovascular events.

"If extended numbers of subjects treated with [the] 30-mg dose demonstrated lower cardiovascular risk than [that] seen at 60 mg, we might be more comfortable with that," said panel member Kathleen M. O'Neil, MD, an associate professor of pediatrics at the University of Oklahoma School of Medicine.

"I would like to see a study that basically took individuals who were not helped, or not getting the benefits of an existing drug, and were then crossed over or moved over to this particular drug to see if, in fact, there is a population who can benefit from this," said Dennis C. Turk, PhD, the committee's acting chair.

During the sponsor presentation, representatives for Merck disclosed the possible cardiovascular and gastrointestinal problems that could occur from regular use of Arcoxia, but they said the drug was still a viable treatment option for OA sufferers.

Merck presented data from a trial involving 35,000 patients, which compared Arcoxia to diclofenac, a NSAID marketed for more than 30 years. However, panelists questioned whether diclofenac was an appropriate drug to use for comparison. They suggested that naproxen [Aleve; Bayer HealthCare] would have been a better choice, since diclofenac is prescribed less than 5% of the time in United States.

Panelists were also hesitant to recommend approval of a drug that could cause major health problems when they are not sure there is a need for another drug of its type on the market. In particular, some voiced concern over a possible recurrence of the adverse events and fall-out associated with the Vioxx withdrawal.

Merck representatives stressed the importance of providing patients with options for treating their OA but could not convince the panel of Arcoxia's efficacy.