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US rejects Vioxx-like drug

1st May 2007

The US Food and Drug Administration (FDA) has turned down an approval application for a drug manufactured by Merck & Co. which is similar to Vioxx, a pain reliever for arthritis patients which was removed from the US market in 2004 because of an increased risk of heart attack and stroke.

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The FDA advisory panel voted 20 to 1 to reject the application for Arcoxia (etoricoxib), which belongs to a class of non-steroid anti-inflammatory drugs used to treat pain and swelling caused by osteoarthritis.

"We are disappointed with today's decision," Merck Research Laboratories president Peter S Kim said in a statement on Merck's corporate website.

"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.  In addition, there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors," Kim said.

Arcoxia is available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.  Merck will continue to market the drug outside the US, where it has been approved for a broad range of indications, the company said.

Osteoarthritis is a joint disease that mostly affects cartilage, the slippery tissue that covers the ends of bones in a joint. While healthy cartilage allows bones to glide over each other and helps absorb shock of movement, in osteoarthritis, the top layer of cartilage breaks down and wears away.

Merck pulled its previous arthritis drug Vioxx from the US market in 2004 after a study showed the drug was linked to a doubled risk for heart attack and stroke, a move which spawned a flurry of lawsuits and sent the company's shares plummeting.

David Graham, who was a key critic of Vioxx, said approving Arcoxia might prompt a public health disaster. He told the panel that Arcoxia might increase the risk of stroke and heart attack and was no more effective for pain relief than other medicines in the same class.

COX-2 drugs are not normally regarded as better painkillers than older NSAIDS like ibuprofen, but they are popular with doctors because they cause fewer gastrointestinal problems.

Merck had hoped to re-enter the US Cox-2 market with Arcoxia, but panel experts criticised the company's use of scientific data in making its case for the drug's approval.

David Felson, professor of medicine at the Boston University School of Medicine and a member of the advisory panel, said: "There is nothing special about this drug that would warrant giving it to patients and putting them at risk of cardiovascular death."


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