Sanofi-Aventis, developer of the highly anticipated drug Acomplia (rimonabant), has provided a new hint that may have asked U.S. and European regulators to approve Acomplia for treatment of "metabolic disorders" as well as for promoting weight-loss and smoking cessation.

But if that's the case, what is the status of the request for approval of Acomplia for treatment of "metabolic disorders?"

Two months ago, the secretive French pharmateutical giant said in a terse announcement that the U.S. FDA had found Acomplia "approvable" for weight management -- but that it was delaying action until unspecified conditions were met -- and had found it "not approvable" as an aid to smoking cessation.

When an analyst subsequently asked why Sanofi had only reported on the "approvable" letter for weight management and the "non-approvable" letter for smoking cessation, and hadn't mentioned the FDA's position "on other indications that I believed you filed on," Senior Executive Vice President Gerard Le Fur brushed the question aside.

But buried on page 40 of a 277-page Form 20-F filing that Sanofi submitted to the U.S. Securities and Exchange Commission this week is the following sentence:

"In terms of regulatory submissions, two major NDAs (New Drug Applications) were submitted in April 2005 in the United States and Europe for rimonabant (obesity, metabolic disorders and smoking cessation) and in June 2005 for dronedarone (atrial fibrillation)."

It would appear, based on this official filing with the U.S. agency that oversees sale of Sanofi-Aventis securities in the United States, that the company is indeed seeking approval of Acomplia for at least one treatment indication related to metabolic disorders.

Our sources previously have said Sanofi tried for indications that included three metabolic syndrome risk factors in hopes the FDA would approve at least some obesity-related complications, thereby increasing the likelihood of expensive Acomplia prescriptions being covered by health-insurance.

So if weight-management is on hold and smoking cessation has been turned down, where does the effort to get the FDA to approve these other indications stand?

The millions of people around the world who had their hopes raised by Sanofi's 2004-2005 campaign to build excitement about its wonder diet pill deserve a rare dose of candor about what still must be done before it can be brought to market.