NEW YORK – Merck & Co. (MRK) said Friday that U.S. regulators have rejected its experimental arthritis drug Arcoxia, the drugmaker's follow-up to Vioxx, saying it could not be approved without new supportive data.
Wall Street had expected the negative decision by the U.S. Food and Drug Administration after an advisory panel to the agency recommended Arcoxia not be approved earlier this month.
Merck had been awaiting approval since December 2003 for the oral medicine, which is already sold in more than 60 other countries. Merck had asked the FDA to approve 30- and 60-milligram doses of Arcoxia to treat osteoarthritis — the most common form of arthritis caused by wear and tear of the joints.
Recent studies of 90-milligram doses of Arcoxia — the dose widely used overseas to treat rheumatoid arthritis — have linked Arcoxia to elevated rates of blood pressure, tissue swelling that can lead to heart problems and congestive heart failure. The same problems had been seen in studies of Vioxx, which Merck withdrew in September 2004 after it was linked to heart attacks among long-term users.