Sanofi-Aventis SA Faces Challenges on Acomplia

By Alexander Toldt
13:05, November 19th 2007
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Sanofi-Aventis SA Faces Challenges on Acomplia

Sanofi-Aventis SA faces new challenges on its obesity drug Acomplia, after alarming studies were published on Friday in two scientific magazines: The Lancet and the British Medical Journal. The French drugmaker’s problems follow the recent launch in the United States of a lawsuit against the company because of its allegedly making misleading statements about Acomplia.

Sanofi-Aventis represents the third pharmaceutical company of the world, but in June it had to pull its application for marketing approval of the obesity drug in the United States, because the Food and Drug Administration rejected the drug over concerns of psychiatric side effects. Since then, the French drugmaker’s stock has fallen 17 percent, while the company has been planning to resubmit the application to the FDA once it gathers new information from ongoing clinical trials.

But the studies published on Friday in the two scientific magazines came before Sanofi-Aventis’s own test results and confirmed the Food and Drug Administration’s concerns on Acomplia’s severe psychiatric side effects. According to the studies, not only does the obesity drug increase the risk of depressed mood disorders and anxiety, but it is also almost ineffective against obesity, as people lose less than 5 percent of their total body weight.

Sanofi-Aventis’ spokesman stated that the company “believes that the meta-analyses do not reveal new objective data given what is already known by the medical communities and the Health authorities." He also said that only the patients that already suffer from depression are affected by what the two studies called Acomplia’s side effects.

Acomplia, which is known to American consumers as Zimulti, is marketed in 21 countries outside the Untied States and reached important sales in the recent period.



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