Serious Setback for Sanofi

The Sanofi-Aventis drug has been before the FDA since April 2005. Since the application was filed, the agency had asked the company for more information about potential psychiatric side effects.

Sanofi-Aventis said earlier this week, in documents released on the FDA's Web site, that it would implement a plan "to minimize identified and potential important risks," namely "depressive disorders, including the potential for suicidality-related events," anxiety, sleep disorders and dizziness.

"Since obesity is a chronic disorder, short-term use is not recommended and the company does not intend to promote the product for short-term cosmetic use," Sanofi-Aventis said. The company said the benefits outweigh the risks.

Prior to the advisory panel meeting, some analysts feared that the committee would ask for more clinical trials -- an expensive, time-consuming effort -- or recommend that the drug be approved with strict limits.

The Zimulti vote came two days before a new weight-loss drug from GlaxoSmithKline(GSK) reaches the U.S. market.

Glaxo's drug, called Alli, will be sold over-the-counter. Alli is a half-strength version of the prescription weight-loss drug Xenical from Roche.

Xenical has had only modest success in the U.S., as has another prescription weight-loss drug, Meridia, from Abbott(ABT). An abundance of side effects and a lack of insurance coverage have suppressed their showings.

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