Merck drug not expected to get OK
NEW YORK -- Merck & Co.'s arthritis drug Arcoxia, the planned successor to its withdrawn Vioxx painkiller, probably won't win US clearance because studies suggest the product raises the risks of heart attacks.
Regulators and doctors are skeptical of Merck's assertion that Arcoxia is safer than Vioxx, and research findings haven't backed up the company, said Steve Nissen, head of cardiology at the top-rated Cleveland Clinic. Analysts including Orbimed Advisors LLC's Trevor Polischuk predicted the Food and Drug Administration will reject the drug.
Failure to win approval would dash Merck's plan to recoup some of the $2.5 billion in annual revenue lost when Vioxx was withdrawn in 2004 after being linked to heart attacks and strokes. If approved, Arcoxia sales might reach $1 billion a year and would signal that Merck had finally rebounded from the Vioxx setback, some analysts said.
"The studies that have been done do not support the approval," Nissen said in a telephone interview yesterday. The Cleveland Clinic has been ranked the top heart center by US News and World Report for more than a decade. "I just can't imagine this is going to be recommended. Where is the advantage here? Do we really want to let this genie out of the bottle?"
The FDA's arthritis advisory committee will consider Merck's Arcoxia application April 12. The company, based in Whitehouse Station, N.J., proposes to sell Arcoxia to treat osteoarthritis, pain usually associated with aging in which repetitive use of joints causes cartilage to become inflamed.
Merck shares rose 37 cents to $45.38 in New York Stock Exchange composite trading.
Arcoxia should win approval because it is safer on the stomach than some popular pain drugs and provides an alternative for patients who have failed on other therapies, Merck said.
"As long as people suffer from pain, either from arthritis or other chronic conditions, there will always be a need for additional treatments to combat it," said Raymond F. Kerins, a Merck spokesman, in an e-mailed response to questions.
