has withdrawn its application for the obesity treatment Zimulti that was filed with U.S. regulators, but it said it will consider resubmitting the drug.
The decision, announced Friday, is a major blow to the company's revenue projections. Still, the action isn't so surprising in light of a demonstrative rejection of the drug by a Food and Drug Administration advisory panel on June 13.
Outside medical advisers to the FDA unanimously voted against the drug, saying Sanofi-Aventis hadn't provided enough safety information.
The advisers said the drug's risks of psychiatric side effects were greater than its weight-loss benefits. They also concurred with an FDA staff report that trial data showed a heightened risk of suicidal thinking.
The staff review of the data showed 26% of patients taking Zimulti exhibited psychiatric side effects vs. 14% taking a placebo.
The FDA was supposed to vote in late July on Zimulti, which is known as Acomplia in foreign markets. Although the agency isn't bound by advisory panel recommendations, it usually follows them.
Sanofi-Aventis shares were down 36 cents, or 0.9%, to $40.23. The company said it is "confident in the positive benefit-risk ratio of
Zimulti when used in the appropriate population." The company added that it is "committed to taking all steps necessary" to make the drug available in the U.S.
The weight-loss drug is approved in 42 countries and sold in 20. Analysts had been predicting that it could produce at least $1 billion in annual sales worldwide -- and maybe twice as much, or even more, if it had gained quick approval in the U.S.
Despite approval in big markets such as the European Union, the drug ran into several regulatory roadblocks in the U.S. The initial application to the FDA was filed in April 2005, but the FDA later asked for more information about side effects.
Sanofi-Aventis subsequently said it would initiate a risk-management plan to guard against the drug's use by people with a possibility for depression or "suicidality-related events." Health care regulators at the EU have said they would review psychiatric side-effect information.