FDA bars Vioxx-successor Arcoxia

April 28, 2007|By McClatchy-Tribune

PHILADELPHIA -- In a widely expected move, Merck & Co.'s arthritis drug Arcoxia was rejected by U.S. regulators yesterday amid concerns that it could pose some of the same cardiovascular risks as the company's withdrawn pain-reliever Vioxx.

The Food and Drug Administration said it wanted more data showing that the benefits outweighed potential risks before approving Merck's successor drug to Vioxx, the company said.

Merck said the FDA issued a "non-approvable" letter for Arcoxia stating that "Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval."

Two weeks ago, an FDA advisory panel voted 20-1 against approval of Arcoxia to treat osteoarthritis because of a possible link to increased risks of heart attacks and strokes.

Arcoxia is in the same class of pain-relieving drugs as Vioxx, called cox-2 inhibitors. Vioxx was pulled off the market by Merck in September 2004.

"We are disappointed with today's decision," said Peter S. Kim, president of 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."

Arcoxia is on the market in 63 countries and Merck said it would continue selling the drug outside the United States. Arcoxia had sales of $265 million last year.

"At this time we are evaluating the FDA's letter," company spokesman Ron Rogers said.

Kim told shareholders at Merck's annual meeting this week that the company was committed to working with the FDA to get Arcoxia on the U.S. market.

He said yesterday that "there is more long-term safety data from controlled clinical trials" for Arcoxia than for any other cox-2 drugs and traditional anti-inflammatory medicines.

"I think they will conduct the additional studies and resubmit at some future point," Herman Saftlas, an analyst at Standard & Poor's, said. "That's my gut feeling. I don't think they will just throw away this drug. It's being sold extensively overseas."

Currently, only one cox-2 inhibitor, Celebrex, made by Pfizer Inc., is still sold in the United States.

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