In a widely expected decision, the FDA has sent Merck a "non-approvable letter" for Arcoxia. The letter said before Arcoxia has another chance at approval, Merck needs to provide more test results showing that Arcoxia's benefits for the treatment of osteoarthritis with the proposed doses outweigh its risks. Two weeks ago, an FDA advisory panel shot down Merck’s application 20-1. That panel rejected the 30-milligram and 60-milligram doses of the drug. The reasons stated were that the medicine showed significant risk of cardiovascular damage and that the drug had not shown any benefits over the approximately 20 pain relievers already on the market. Other U.S. studies of 90-milligram doses of Arcoxia have shown increased risk of elevated blood pressure, tissue swelling that can lead to heart problems, and congestive heart failure.
Arcoxia is sold in 63 other countries, most often in the 90-mg dose. However, FDA approval of the drug has been pending since December 2003. This was around the time that Merck’s other major COX-2 inhibitor, Vioxx, was coming under fire for its risks of cardiovascular damage. Soon after Vioxx was pulled from the market, Merck was told that it would have to provide further safety and efficacy information about Arcoxia.
Merck produced additional results used in its most recent application, but many physicians, including the FDA advisory Panel questioned the way Merck set up the studies- choosing an older NSAID, diclofenac, which is widely used in other countries, but not here. That drug also has an elevated risk of heart attack and stroke. Merck maintained that the two drugs have similar cardiovascular risk, though Arcoxia causes high blood pressure in more patients.
Worldwide, Merck made $265 million from Arcoxia last year, but since the U.S. is the world’s most expensive and profitable drug market, it would have brought in much more revenue for Merck. This might still be small though, compared to the $2.5 billion Merck averaged per year during Vioxx’s peak.
Published On: April 30, 2007