Weight loss Tips

It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti.

Sanofi-Aventis, developer of rimonabant which is now sold in a number of European countries, Argentina and Mexico as Acomplia, has long been coy about what name it intends to use if the FDA approves the diet drug for U.S. sale.

But the pros-and-cons of rimonabant are cheduled to be aired by an FDA advisory panel on June 13th, and the official notice of the hearing published in the Federal Register says the panel will discuss "the efficacy and safety of new drug application (NDA) 21-888, proposed tradename Zimulti (rimonabant)."

The meeting notice published by the FDA Endocrinologic and Metabolic Drugs Advisory Committee also is interesting in that would appear to dash suggestions made by some of Sanofi's favorite financial analysts that the FDA may now approve Acomplia / Zimulti for treatment of type 2 diabetes.

The published notice says the FDA panel will consider rimonabant "as an adjunct to diet and exercise for obesity management in patients with a body mass index equal to or greater than 30, or a body mass index equal to or greater than 27 if accompanied by at least one cardiovascular risk factor."

This not only does not sound like treatment of diabetes, but it also does not sound like an indication for treatment of "metabolic syndrome," which is a package of cardiometabolic risk factors.

If "obesity management" indeed does become the FDA-approved indication, the question of whether U.S. insurers will agree to pay for the diet drug would appear to be very much up in the air.

In Europe, the German state insurance system has classified Acomplia a life-style drug and has rejected reimbursing patients, and the French government has agreed to provide partial coverage only for obese (not simply overweight) patients who also have inadequately controlled type 2 diabetes.

Resources: http://www.acompliareport.com/News/news-040507.htm