April 17, 2007
FDA panel rejects Merck’s Arcoxia
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.