Novartis’ COX-2 inhibitor, Prexige (lumaricoxib), and Merck & Co’s Arcoxia (etoricoxib), could both pose a cardiovascular risk, according to information posted on the US Food and Drug Administration’s website late last week ahead of the advisory panel meeting that will assess the safety of this class of products [[17/01/05a]]. Although neither of these drugs is approved in the US [[24/09/03a]], [[05/01/04b]], the second day of the panel meeting will focus on Arcoxia and Prexige, including a review of data that conclude that each has a potential cardiovascular risk.
Although Aroxia offers a “marginal” benefit to gastrointestinal safety, it is not thought to be as good as other products in terms of death and serious cardiovascular side effects, according to a Reuters report, citing regulatory staff documents. The article also reported that Prexige had a similar cardiovascular safety profile to Merck & Co’s Vioxx (rofecoxib), which was withdrawn from the market last year [[01/10/04a]]. However, the agency also noted that Prexige was the only COX-2 inhibitor to show a “significant” benefit in terms of gastrointestinal safety versus other non-steroidal anti-inflammatory drugs.
At its meeting, the FDA panel will specifically review the cardiovascular safety profile of COX-2 inhibitors and whether the risk that prompted Merck to withdraw Vioxx, is in fact a class effect. The first day of the meeting will begin with a reminder of the “hope” that originally drove development of the class, followed by an overview of the risks of gastrointestinal adverse events from NSAIDs and presentations on the cardiovascular safety data from the three COX-2 inhibitors that are approved in the US – Vioxx, and Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib).
“Based upon all of the information currently available, many in the public, the scientific community and [the] FDA have raised questions about whether there should be continued marketing of COX-2 selective NSAIDs,” the memo for committee members notes. “What is your view? Is there a patient population for whom the risk is warranted, given the known potential for benefit? If COX-2 drugs continue to be marketed, how much and what kind of information is necessary in order to justify the marketing of a new COX-2 selective NSAID?”