CELEBREX: Wins FDA Approval, With Caveat
The Food and Drug Administration Thursday gave long-awaited approval to Monsanto Co.'s much-touted painkiller Celebrex, but withheld a coveted labelling claim that would have allowed the company to say the drug causes fewer gastrointestinal side-effects than its older competitors. Developed by Monsanto's G.D. Searle pharmaceutical division, Celebrex is the first in a new class of painkillers called COX-2 inhibitors to be approved for market. The company has hailed Celebrex as a boon for the almost 20 million Americans afflicted with rheumatoid arthritis or osteoarthritis, who often suffer from debilitating or deadly stomach ulcers from their painkillers. The FDA, however, "will not allow the St. Louis-based company to claim that Celebrex avoids" such ulcers (Burton/Sharpe, Wall Street Journal, 1/4). Investor's Business Daily reports that Searle's trials "showed patients taking Celebrex had fewer mini-ulcers. But these often heal on their own, so the big question is whether long-term Celebrex users ultimately suffer fewer" side effects (1/4). The Celebrex label will carry the same ulcer warning as other painkillers, "noting that such problems occur in about 2 to 4% of patients treated." It will allow, however, that it is "unclear whether that rate will apply to patients who use Celebrex" (Bloomberg News/Boston Globe, 1/1). Murray Lumpkin, the FDA's deputy director for drug evaluation, said that Celebrex holds "the promise of being safer, but that question has not been fully answered yet." A final determination will require "a trial of several thousand patients that would look at outcomes like (gastrointestinal) bleeding, ulcers and blockages," he said (Journal, 1/4).
Although disappointed with the labelling restriction, Searle officials expressed optimism over the drug's future. CEO Dick De Schutter said, "I think the medical community is very familiar with this drug, and recognizes its significance. We expect as the drug finds widespread use in millions of patients -- and as we continue to set up new clinical trials -- that (elimination of side effects) will be established beyond a doubt" (Cimons, Los Angeles Times, 1/1). COO Al Heller added, "We certainly expect to be able to get rid of that" warning label (Bloomberg/Globe, 1/1). But independent analyst Hemet Shah said, "It's kind of disappointing. I'm actually surprised Monsanto agreed to the label." He said the restriction will hinder the company's ability to market the drug directly to consumers, which will make it "difficult for Celebrex to become a $1 billion drug" in 1999 (Journal, 1/4). He added, "If you don't have a side effect advantage, why would anybody use a product that is 10 to 20 times more expensive and at the same time offers no advantage over ibuprofen and other generics?" (Bloomberg/Globe, 1/1). Monsanto said the drug will cost $3 per day, comparable to other prescription painkillers (Los Angeles Times, 1/1). "We are not pricing it at a premium," said De Schutter.
Other COX-2 inhibitors, such as SmithKline Beecham's Relafen and Merck's Vioxx, anticipate approval later this year. But "Celebrex will be a potent competitor to those drugs, since clinical trials show that it was associated with far fewer visible ulcers than some of them" (Journal, 1/4). The AP/Washington Times reports that Merck may be holding out for a more favorable label once results of further studies become available. "Merck may be able to use Monsanto's experience to get a better label," said Sergio Traversa, an analyst with Mehta Partners (Galewitz, 1/2). A COX-2 inhibitor which can make the important claim on its label are "expected to achieve annual sales of as much as $5 billion" (Bloomberg/Globe, 1/1).