Weight Loss News

Acomplia, the new weight-loss pill from Sanofi-Aventis, has not yet been approved in the United States because of questions about its safety. But some Americans have decided not to wait.

Many are traveling to Europe, where the drug has been approved, or buying the medicine through foreign Web sites, while the U.S. Food and Drug Administration continues its evaluations of the treatment. On Monday, a panel of advisers to the agency said that the pill might raise the risk of suicide and suicidal thoughts.

"I don't have very many years to go, and I don't want to spend that time over 200 pounds," said Yvette Cardozo, a 62-year-old American photographer who bought six months' worth of Acomplia during a trip to London. "This is the only thing that's ever worked for me."

Twenty milligrams of Acomplia, the highest dose, resulted in statistically and clinically significant weight loss, the Food and Drug Administration's staff said in documents posted Monday on the agency's Web site. The agency advisory panel will meet Wednesday to discuss whether the medicine's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.

Since clinical tests have shown that the drug can cause anxiety and depression, analysts said the panel might be cautious about approving it without seeing more studies.

Once approved, Acomplia might be used by millions who just want to shed a few pounds, says Nick Turner, an analyst at Mirabaud Securities in London. As a result, side effects not revealed in patient trials could arise, he said.

"The major issue with Acomplia appears to be the neurological or mood disorders," said Turner, who has a neutral rating on Sanofi stock. "People won't take this drug because it helps their diabetes, they'll take it because somebody promises them that they'll become slim."

Sanofi has predicted at least $3 billion in annual revenue from the drug. Shares of Sanofi fell 5 cents Monday to close at €67.52 in Paris.

Sanofi officials have repeatedly said that the drug was not for those trying to fit into a party dress.

"Acomplia is not a cosmetic product," Gerard Le Fur, the chief executive of the company, said at the company's annual meeting in May.

The French drugmaker needs the medicine to shore up its activities in the United States, where a third of the population is considered obese, as its older best-sellers, like the sleeping pill Ambien, lose patent protection.

Sanofi had expected Acomplia to be approved last year, but the Food and Drug Administration demanded more information in February 2006. This year, Sanofi said the FDA would need until July to complete its review.

Patients given the highest dose of the drug lost an average 5.3 kilograms, or 11.7 pounds, over a one-year period compared with a weight loss of 1.4 kilograms among patients given a placebo.

Cardozo, the photographer, said that she had lost 20 pounds since restarting treatment after participating in Sanofi clinical trials five years ago. She lost 30 pounds during those tests, and said Acomplia was the only drug that had helped her shake excess weight that had plagued her since her teens.

http://www.freewebs.com/acomplia

"If I have a drug that's gone through clinical trials and is not poison, and it works for me, then I'm happy to take it," said Cardozo, who is 5 feet 7 inches, or 1.7 meters, tall and weighs 190 pounds.

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