|
|
After the Recall, Merck Talks About a Successor to Vioxx
The New York Times
October 14, 2004
Merck & Company, the drug maker that recalled its painkiller Vioxx because of a link to heart disease, said yesterday that short-term studies had shown its planned successor, Arcoxia, to be safer.
Merck will present safety findings on Arcoxia next week at the American College of Rheumatology's annual meeting in San Antonio, Peter S. Kim, president of Merck's research laboratories in Whitehouse Station, N.J., said at a news conference. The company is seeking United States regulatory approval to sell the new medication, which is the same class of drug, COX-2 inhibitor, as Vioxx.
The company withdrew Vioxx after a study showed that patients who took it for more than 18 months had twice the risk of a heart attack as those who took a placebo. The Sept. 30 recall, the biggest ever for a prescription medicine in the United States, wiped out $26.8 billion of Merck's market value that day. Vioxx generated $2.5 billion, or 11 percent, of Merck's sales last year.
"We do have substantial safety data on Arcoxia," Mr. Kim said. But executives said they did not have safety findings for people who took the medicine as long as 18 months, when the Vioxx risk showed up.
Mr. Kim said he would not speculate whether the Food and Drug Administration may delay approval of Arcoxia because of the Vioxx withdrawal. An F.D.A. decision on the application is expected by Oct. 30.
Timothy Anderson, an analyst at the Prudential Equity Group, and Richard Evans, an analyst at Sanford C. Bernstein, have published reports saying that the F.D.A. will probably require more data on Arcoxia's safety before approving it.
"The data that we have around Arcoxia basically indicates that there are no safety issues," Raymond V. Gilmartin, Merck's chief executive, said on the financial news network CNBC. "That has been the basis of its approval in Europe and also in the other countries."
More research is needed to determine whether Vioxx's heart risk applies to all COX-2 inhibitors, said Dr. Eric J. Topol, the Cleveland Clinic's chairman of cardiovascular medicine, in a telephone interview.
COX-2 drugs, which include Bextra and Celebrex, both by Pfizer, are intended to be gentler on the stomach than medicines like ibuprofen.
|
|
