FDA rejects Merck successor to Vioxx

The Food and Drug Administration rejected Merck & Co.’s request to market a successor to its withdrawn arthritis drug Vioxx in the U.S., the drug maker said Friday.

The decision was widely expected after a panel of FDA advisors two weeks ago voted 20 to 1 against approving the drug, called Arcoxia.

Arcoxia is one of the anti-inflammatory drugs known as Cox-2 inhibitors, which are touted as less likely to cause stomach bleeding or pose other dangers, but they have been linked to heart risks. It is the same class of drugs as Vioxx, which has become a poster child for drug safety problems.

Merck pulled Vioxx from the market in September 2004 after research showed that it doubled the risk of heart attack and stroke. That triggered an avalanche of lawsuits -- more than 27,000 so far -- and a nose dive for Merck’s stock price, which has since rebounded.

Despite the safety concerns in the U.S., Arcoxia is sold in 63 other countries. It brought in revenue of $265 million last year, up 22% from 2005, but barely one-tenth of the $2.5 billion a year Vioxx fetched at its peak.

As recently as Tuesday, Merck executives said they intended to keep working to put Arcoxia on the U.S. market, the most lucrative in the world.

Spokesman Ron Rogers said Merck would not discuss whether it will drop efforts to get Arcoxia approved domestically.

Analyst Steve Brozak of WBB Securities said Merck officials were “just going through the motions” in seeking FDA approval.

“This is it. Put a fork in it and it’s done,” he said.

Arcoxia had been poised for approval until Vioxx was pulled from the market. Two months later, the FDA issued a letter saying it could approve Arcoxia if Merck provided further information on the drug’s safety and effectiveness.