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news.A painkiller manufactured by Merck & Co. that had been heralded as the successor to the controversial Vioxx medicine has been rejected by an FDA advisory committee.
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The committee said it voted against recommending the drug Arcoxia, for the treatment of osteoarthritis, because data suggests the drug is no more effective than similar drugs in the same class. The FDA is not bound by the committee’s recommendation but takes its advice into consideration when reviewing the application for an investigational agent.
The drug is the first of its class to seek FDA approval since Merck withdrew Vioxx from the market because of its link to cardiovascular side effects. Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since the new drug application was submitted in December 2003. The drug is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region, the Middle East and Northern Africa.
“We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis,” said Peter Kim, president, Merck Research Laboratories.
“We are committed to continuing to work with the FDA to discuss the application in an effort to gain US regulatory approval for Arcoxia.”
Merck presented data from a clinical program that included efficacy and safety findings for Arcoxia 30mg and 60mg once daily from studies in patients with osteoarthritis.