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Diet Drug Acomplia Still Has No Date With Key FDA Advisory Panel

The U.S. Food and Drug Administration on October 10th posted an updated schedule for its advisory committees with still no indication that a key panel will meet to weigh the pros and cons of diet drug Acomplia (rimonabant) during the final weeks of 2006.

The Endocrinologic and Metabolic Drugs Advisory Committee, which would be the panel of independent experts that would be asked to advise the FDA on approval of Acomplia, has no meetings scheduled at this point for the balance of the year.

While the FDA is not required to seek an advisory panel's advice before acting on Acomplia, few observers believe the agency -- already under fire for letting drugs come to market that later turn out to have serious side effects -- will act on its own to approve a novel drug that works on receptors in the brain.

The absence of any sign that the advisory panel plans to meet anytime soon would appear to even further undercut Sanofi's reiteration last week that it remains hopeful and confident that the FDA will approve Acomplia for sale in the United States (presumably under the name Zimulti) before the end of 2006.

Even financial analysts who largely have been inclined to parrot Sanofi's forecasts of an early U.S. introduction of Acomplia are now taking a more skeptical view.

Morgan Stanley reported yesterday it now believes FDA action on Acomplia is likely to be delayed to 2007, though it said it continued to believe that the highly anticipated diet drug will be approved for sale in the U.S. "in the next 12 months."

Financial analysts for the German bank WestLB went further, saying that believed Sanofi's launch of Acomplia in the U.S. would not take place before the second quarter of 2007.

Questions about Acomplia have been snowballing since a research analyst who has been one of the biggest boosters of Sanofi sent a note to investors saying the company had gone silent to most investors, analysts and the media, and would remain quiet until it announces quarterly financial results on Oct. 31.

This decision not to let anyone know what is going on gives Sanofi's shareholders "plenty of reason to be nervous," Forbes magazine reported on October 5th.

U.S. approval of rimonabant, Forbes notes, has been delayed for seven months and counting.