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Acomplia News from November 2005 -- News About Rimonabant
 

Is No News Good News for Acomplia?

 

In the past month, the new anti-obesity drug Acomplia (rimonabant) has virtually disappeared from the news, leading a number of the millions of overweight men and women who had been hoping it might be available before the end of the year to wonder what's going on.

Well, what we can report now with as much certainty as you ever get is that Acomplia will not be approved by the U.S. Food and Drug Administration during the remainder of 2005.

In fact, the U.S. Food and Drug Administration advisory committee that is expected to weigh in on Acomplia prior to an FDA decision on approval apparently no longer intends to even hold the meeting that had been tentatively scheduled for December 13th-14th.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which reviews and evaluates data concerning the safety and effectiveness of investigational drugs for use in the treatment of endocrine and metabolic disorders, customarily meets four times a year.

But Cathy Groupe, the FDA staffer who serves as executive secretary of this advisory committee, informed the Acomplia Report that "there are currently no scheduled dates on the 2005 or 2006 calendar for meetings of the Endocrinologic and Metabolic Drugs Advisory Committee."

Virtually all observers believe it highly unlikely that the FDA would approve a novel drug that is the first endocannabinoid-receptor inhibitor to be brought before it without any input from one of its advisory committees.

The developer of a drug, Sanofi-Aventis in the case of Acomplia, would need to be invited to attend 60 days in advance of any meeting where the drug was to be discussed -- so the first quarter of 2006 would not be the earliest that the committee could consider issues involved in approval of Acomplia.

Meanwhile, the steady drumbeat of news that came out of the Phase III trials of Acomplia has pretty much dried up because all of the major trials conducted as part of the new drug approval process have been concluded.

A new clinical trial of Acomplia that will explore the value of the drug in helping prevent the development of coronary artery disease in obese and overweight people at high risk is believed to be enrolling participants at research centers in the United States, Canada, Europe and Australia. But Sanofi has never formally announced this trial, or provided any information about its structure, or goals and objectives.

So about the only news regarding Acomplia most days comes from investment researchers attempting to divine from tea leaves when Acomplia might be approved, and how that will impact the price of Sanofi's stock.

The investment firm Bear Stearns on Nov. 3 cut its rating of Sanofi's stock from outperform to peer perform, noting that "deadlines have not moved in Sanofi's favor" including the deadline for "Acomplia's FDA panel."

J.P. Morgan, on the other hand, four days earlier upgraded Sanofi to overweight from neutral, predicting approval of Acomplia in early 2006 and forecasting the drug would become a blockbuster with worldwide sales amounting to $6 billion a year by 2010.

So you pay your dollar (or Euro) and take your pick. Is no news about Acomplia good news? For the moment, we will leave that call to you.

 
 
 
 
 
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This is an independent news site reporting on rimonabant, a diet drug developed by Sanofi-Synthelabo Inc., which plans to market it under the trademarked name Acomplia. Nothing on this site is intended to infringe on that trademark. Nothing on this site is intended as medical advice. The information provided here is for informational purposes only. Always consult a doctor or medical professional with questions you may have regarding a medical condition.

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Last Updated: 11/08/2005