FDA panel rejects Merck’s Arcoxia

Share this article:
An FDA advisory panel voted against the approval of Merck’s Vioxx-successor Arcoxia (etoricoxib) as a treatment for osteoarthritis. The nonbinding vote on the drug was 20-1. The FDA is not required to follow the recommendations of its advisory panels, but usually does. Merck said it expects the FDA will make a final decision on Arcoxia by the end of the month. During a conference call with reporters after the Arcoxia vote, Robert Meyer, director of CDER's Office of Evaluation II, said that the committee was particularly concerned about the cardiovascular safety of the drug. Such risk concerns, he added, could mean that future NSAID or coxib agents could have to show a unique benefit to gain marketing approval. “It seems like [the committee] had concerns that, if there was just another product with the same level of risks of those out there now but no unique benefit, that...didn’t seem to be sufficient reason to approve such a product,” he said.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

The Women's Health landscape is ripe with opportunity for pharma marketers. This seven-page eBook offers product managers a guide to capitalizing on the trends, growth areas and unmet needs. Includes alternative channels to engage OB/GYNs and oncologists, and plenty of tips. Click here to access it.