- The Washington Times - Friday, April 27, 2007

The Food and Drug Administration turned down Merck & Co.’s attempt to market a new arthritis drug following evidence it has side effects similar to the company’s banned drug, Vioxx, Merck said yesterday.

The expensive and lengthy process that resulted in a rejection highlights skepticism over the class of drugs known as Cox-2 inhibitors since September 2004, when Vioxx was found to double the risk of heart attacks and strokes.

Merck submitted a new drug application to the FDA for Arcoxia in December 2003, following a forced withdrawal of the company’s original arthritis drug Vioxx. Merck announced the FDA’s decision yesterday.

“We are disappointed with today’s decision,” said Peter Kim, president at Merck Research Laboratories. “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.”

An estimated 21 million people in the United States suffer from osteoarthritis. Cox-2 inhibitors, a type of anti-inflammatory therapy, are developed to be gentler on the stomach than other medications but have run into problems because of an increased risk of heart attacks.

Merck asked the FDA to approve Arcoxia to treat osteoarthritis, the most common form of arthritis.

Studies linked Arcoxia to elevated rates of blood pressure and tissue swelling that can lead to heart problems and congestive heart failure, the same problems that had been seen in studies of Vioxx.

Making the FDA’s decision mildly surprising is the fact that Arcoxia is available in 63 countries abroad including in Europe, Latin America and Asia. In addition, the FDA sent Merck an approval letter for Arcoxia in 2003, giving the company the go-ahead to conduct clinical trials.

Two weeks ago an FDA advisory panel on arthritis drugs recommended the agency reject Arcoxia 20-1. The panel said that to overlook any risk of heart attacks, it would need significantly more data to show Arcoxia is a better painkiller than existing drugs.

The advisory panel has been viewed as a rubber stamp by some that monitor the drug industry. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the advisory panel’s decision is the first time in his over 20 years experience with the panel that it rejected a drug. However, he added that the panel had little choice.

“You would have to be brain-dead to allow any of these drugs [Cox-2 inhibitors] on the market,” he said.

In its letter to Merck this month, the FDA asked for “additional data in support of the benefit-to-risk profile” for Arcoxia to be approved.

Still, the agency decision coupled with the advisory panel’s harsh rebuke of Arcoxia are evidence of a new and more stringent focus by the FDA on Cox-2 inhibitors.

“Was it logical to not approve Arcoxia, yes. But it is going to be tougher for all drug companies to get these types of drugs approved by the FDA after having been burned on Vioxx,” said Bill Vaughn, a policy analyst in the health sector of Consumers Union.

A Merck spokeswoman said the company is in the process of determining the next step for Arcoxia.

Mr. Kim said Tuesday — before the FDA alerted Merck the drug would not be approved — that more long-term safety data on Arcoxia exists than other drugs in the same class and traditional anti-inflammatory medicines.

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