Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has refused to approve Merck & Co.'s COX-2 inhibitor Arcoxia without additional data to support the benefit-to-risk profile of the drug.
Subscribe to our email newsletter
Merck is seeking market authorization for Arcoxia to treat osteoarthritis in the US, where it has been under review since December 2003. The drug is in the same class as Vioxx, which was withdrawn by Merck in 2004 after cardiovascular safety concerns were raised.
The decision from the FDA has been widely expected, after an advisory panel to the agency recently voted 20-1 against approving the drug.
Peter Kim, president of Merck Research Laboratories, said: “We are disappointed with today’s decision. We pursued FDA approval of Arcoxia because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies.”
Arcoxia is available in 63 countries in Europe, Latin America, the Asia-Pacific region, the Middle East and Northern Africa.