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News About Acomplia (Rimonabant)

Medical Week News for October 2005
Will U.S. FDA Advisory Committee Consider Acomplia, and When?

The U.S. Food and Drug Administration advisory committee that is expected to weigh in on the new anti-obesity drug Acomplia (rimonabent) prior to an FDA decision on approval apparently does not intend to take up the drug at its December meeting.

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, meets four times a year. It's next scheduled meeting is December 13th and 14th.

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, and financial researchers for Morgan Stanley report Sanofi has not at this point been invited to the December advisory committee meeting.

Morgan Stanley interpreted this as an indication that the Food and Drug Administration might approve Acomplia without a need for consideration by the advisory panel.

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

These observers believe a deferral of a heated advisory panel debate over issues surrounded rimonabant until sometime in 2006 is far more likely.

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