February 18, 2006
Approval Delayed for Weight-Loss Drug
By STEPHANIE SAUL
Approval for Sanofi-Aventis's experimental drug for weight loss, Acomplia, was delayed yesterday by the Food and Drug Administration, which issued what it calls an ''approvable'' letter but said the company must meet certain conditions before the product could receive final clearance.
An F.D.A. spokeswoman, Kathleen Quinn, said the agency would not disclose exactly what regulators wanted before Acomplia could be marketed, so the extent of the delay was not clear.
A company spokeswoman, Julissa Viana, said the company would continue to work with the F.D.A. to win approval to market the product, but she did not discuss details of the agency's request.
Ms. Viana also said the F.D.A. had turned down an application by Sanofi-Aventis to market the drug for use in smoking cessation.
Investors, who had hoped the product would be on pharmacy shelves by the summer, reacted negatively to the announcement, made after the closing bell on Wall Street. In after-hours trading, shares in Sanofi-Aventis, based in Paris, declined $1.28, or 2.9 percent, to $42.92.
With obesity becoming more common, various financial analysts have predicted that the drug could be a blockbuster, with sales forecasts of $1 billion to $5 billion annually by 2010. But analysts and doctors also have raised concerns about side effects.
In an editorial published Wednesday in The Journal of the American Medical Association, physicians at the National Heart Lung and Blood Institute had questioned whether the drug needed more study before it was sold.
Acomplia aims at the same body mechanism that seems to cause the ''munchies'' in marijuana users, but it has the opposite effect, suppressing appetite. Acomplia is not a cure for obesity, though, according to the company. Patients who take it must also follow a diet to get results.
In a recent clinical trial, those taking the drug for a year along with a diet and exercise program lost an average 7.9 pounds more than those taking a placebo. They also had favorable changes in fat and sugar measurements in the blood, a fact that the company points to as evidence its drug has benefits beyond the cosmetic.
Acomplia is under review as federal officials are under pressure to deal with a national epidemic of obesity.
Since the late 1980's, adult obesity has steadily increased in the United States. Today, 64 percent of all Americans are overweight and more than 30 percent are obese, according to federal statistics.
In 1990, fewer than 56 percent were overweight and fewer than 23 percent were obese.
The weight loss achieved with Acomplia is comparable to that with the two other diet drugs currently approved for long-term use in the United States -- Meridia by Abbott and Xenical by Roche. But each of those drugs has side effects that have curtailed use.
Meridia, sold in the United States since 1997, has been linked to high blood pressure and stroke, although an F.D.A. review recently concluded that it was safe enough to remain on the market. Xenical, available since 1999, has a good safety profile, but its most common side effect -- flatulence, greasy stools and occasional loss of bowel control -- have led doctors to shy away from prescribing it.
Clinical trials of Acomplia, whose generic name is rimonabant, revealed that a few patients reported depression and anxiety, which is a reason some doctors have urged caution. In a research paper, Goldman Sachs predicted that because of those central nervous system side effects, Acomplia would be approved only on the condition the company conducted a rigorous postmarketing surveillance program.
The drug works on receptors in the cannabinoid system, which play a role in controlling metabolism.
The receptors are located in the brain and peripheral organs -- including the liver -- fat and muscle. By sending signals back and forth between the brain and peripheral organs, these receptors control how many calories the body wants to take in.
Some of the receptors were first identified in marijuana research.
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