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.

Next Article in Channel

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...