When Will Sanofi Come Clean on Acomplia and the FDA?

[Guest guest]

When will Sanofi-Aventis, developer of Acomplia (rimonabant), come clean on what the FDA is saying about the issues delaying approval ot the most highly-anticipated weight-loss drug of this century?

Will Sanofi management issue a statement to the media following the discussions officials said they will have this month with the FDA about the "dossier?" Will they even tell us that these discussions have taken place?

Will Sanofi provide further hints to financial analysts when it briefs them on March 22nd in New York? Will Sanofi have more to say when the company reports on its first-quarter earnings May 5th?

Sanofi management has from the start been unwilling to share even the most basic information about its filing with the FDA for approval of Acomplia, and company executives show no signs of changing now.

"We don't intend to communicate on an ongoing basis on our discussions with the FDA," an exasperated executive vice president Hanspeter Spek snapped at analysts trying to pin Sanofi management down to a date for an update.

In point of fact, Sanofi has never even publicly spelled out exactly what uses of Acomplia it asked the FDA to approve in its filing.

While the company said in its Feb. 17th announcement that the FDA was holding up approval of rimonabant for "weight management" and had issued a "non approvable letter" for smoking cessation, weight management wasn't even mentioned in last year's Sanofi announcement of its FDA filing.

The June 17th announcement reporting that the FDA had accepted the application for rimonabant talked of the drug representing "a new approach for the comprehensive management of cardiovascular risk factors."

Acomplia, it said in that news release, provides a "comprehensive management approach to such cardiovascular risk as dyslipidemia, abdominal obesity and insulin resistance, which comprise the metabolic syndrome."

From a variety of insiders and analysts now comes word that Sanofi asked the FDA to approve five indications for Acomplia -- of which weight management and smoking cessation were presumably two --in the New Drug Application filed last summer.

When an analyst asked on Feb. 24 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 replied:

"We do not want to comment on anything, including the PI for sure."

The "PI" would be the Indications and Usage section of the product labeling.

Our sources say 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 effort to get a straight answer out of Sanofi continues.

http://www.dietdrugreport.com/News/news-030706.htm

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