FDA panel rejects Merck's Vioxx successor

GAITHERSBURG, Maryland (Reuters) - Merck & Co Inc.’s successor to the recalled pain reliever Vioxx should not be approved, a U.S. advisory panel ruled on Thursday after members said they saw no advantages over older medicines.

The committee’s rejection in a 20-1 vote makes it unlikely Merck will win permission to sell the drug, Arcoxia, in the United States. Merck expected a final decision by April 27.

The company had argued Arcoxia was as safe as other pain relievers on the market and would be a valuable alternative for arthritis patients who do not respond well to current options.

But members of a Food and Drug Administration advisory panel said they believed Arcoxia could damage the heart and had not shown any benefits over the approximately 20 pain relievers on the market.

“We don’t really have strong data there is a need for this drug,” said Dr. Richard Cannon, a panel member and researcher at the National Heart, Lung and Blood Institute.

Merck pulled Vioxx from the market in 2004 after research found it doubled heart attack and stroke risk. Both Vioxx and Arcoxia target the Cox-2 enzyme involved in inflammation.

They are part of a larger class called non-steroidal anti- inflammatory drugs, or NSAIDs. After Vioxx was pulled, the FDA concluded other NSAIDs also raised cardiovascular risks, but they could stay on the market with strong warnings.

Before the panel vote, FDA drug safety reviewer and Vioxx critic Dr. David Graham warned that widespread use of Arcoxia could lead to “a potential public health disaster” and a “repeat of what we have with (Vioxx).”

Graham and others said Merck’s decision to compare Arcoxia in a large safety study to an older medicine, diclofenac, was inappropriate because it is little used in the United States and among the most dangerous pain relievers for the heart.

Dr. Robert Meyer, head of the FDA office that reviews pain relievers, said he felt the agency “got very clear advice from the advisory committee


“Simply having another drug on the market didn’t, in their opinion, appear to be sufficient reason to approve a product,” Meyer said.

Merck said it was disappointed by the panel’s decision, but would keep selling the drug in other countries and try to work with the FDA to win U.S. approval.

“We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis,” said Peter Kim, president of Merck Research Laboratories.

Arcoxia, known generically as etoricoxib, is sold in more than 60 other countries and 2006 sales were $265 million.

Mehta Partners analyst Shaojing Tong said the panel’s rejection was “widely expected, but the lopsided 20-to-1 vote was a little surprising.”

Tong noted that Merck previously had included U.S. sales of Arcoxia in its earnings forecast for 2007. Even so, he said Merck will not need to lower its forecast because sales of new company products for diabetes and to prevent cervical cancer are growing by leaps and bounds.

Merck tested Arcoxia against diclofenac in one of the largest cardiovascular safety studies ever with 34,000 patients. The company said the trial showed the drug was no more dangerous to the heart than the older medicine.

Merck also said Arcoxia was gentler on the stomach than other NSAIDs, which can cause stomach irritation and more serious problems such as bleeding ulcers in some patients. But FDA reviewers said the most worrisome gastrointestinal effects were about the same for Arcoxia and diclofenac.

Novartis AG also is trying to win U.S. approval for a Cox-2 inhibitor called Prexige.

Before the vote, Merck shares gained 1.56 percent, or 71 cents, to close at $46.36 on the New York Stock Exchange.

Additional reporting by Ransdell Pierson in New York