Industry analysts are predicting U.S. regulators this month will refuse to approve Merck & Co.’s new arthritis drug until at least 2006 because of heart attacks linked to its recalled sister drug Vioxx.
The U.S. Food and Drug Administration is expected to render a verdict by the end of October on the new pill, called Arcoxia, which is in the same class of arthritis drugs as Vioxx and Pfizer Inc’s Celebrex and Bextra medicines. Merck recalled its $2.5 billion-a-year Vioxx last month after twice as many patients taking it for at least 18 months suffered heart attacks as those taking a placebo. That 2,600-patient trial was designed to see if Vioxx could prevent recurrence of colon polyps, which can become cancerous. With the disappearance of Vioxx, which accounted for over 10 percent of Merck’s 2003 revenues, Merck is counting on Arcoxia to help fill the financial void. Before the recall, Wall Street had expected newer Arcoxia to post annual sales of up to $1 billion by 2008. “I think the FDA will now want longer safety trials on Arcoxia and will delay its approval for up to two years,” said Shaojing Tong, an analyst with Mehta Partners in New York. “And I doubt Merck will remain committed to Arcoxia.” Merck officials on Wednesday vowed to fight for Arcoxia’s approval. “We do have substantial safety data on Arcoxia,” Merck research chief Peter Kim said at a press conference in which he defended the company’s decision to continue selling Vioxx before the recall despite 4-year-old trial data suggesting its link to heart attacks. But Kim declined to speculate on whether the FDA would approve Arcoxia, given the now-confirmed dangers of Vioxx. FDA officials could not immediately be reached for comment. Merck’s trials comparing Arcoxia to placebos among patients with arthritis lasted only 12 weeks, of similar duration to placebo-controlled trials submitted to the FDA for approvals of Celebrex and Bextra. Analysts said the higher rate of heart attacks among Vioxx users in the trial that sparked the recall did not become apparent until after 18 months of comparison to placebos. “So I doubt 12 weeks of Arcoxia safety data will be enough to satisfy the FDA,” said Cathay Financial analyst Sena Lund. “I think it will be in the best interests of the FDA and patients to wait for two or three years of data that show cardiovascular risk.”Merck officials said it is unethical to ask arthritis patients to take placebos for longer than 12 weeks, because they need a real drug to control pain and inflammation. But Sean Curtis, a senior Merck researcher who helped develop Arcoxia, said the company expects by early 2006 to complete a long-term trial involving 20,000 patients with arthritis. The so-called MEDAL trial does not compare Arcoxia to placebo. Instead, it compares the experimental medicine to diclofenac, a widely used treatment. “The placebo-controlled Arcoxia data are only three months, but data from ongoing studies will provide our long-term safety” data, Curtis said. Deutsche Bank analyst Barbara Ryan said the Vioxx recall has “raised the bar” at the FDA for data needed to approve similar new drugs, which work by blocking the COX-2 enzyme that causes inflammation. “The FDA won’t feel 12-week placebo data are conclusive and will ask for longer placebo trials or will want to wait for results of the MEDAL trial in 2006,” Ryan said.(Source: Reuters, Oct 2004)