An FDA expert panel unanimously rejected Sanofi-Aventis' Acomplia, its would-be obesity blockbuster, out of concerns regarding the drug's potential side effects. And analysts are concerned that the fallout from that vote could put a big dent in the pharma company's efforts to market the drug in Europe. Some analysts are anticipating a tougher label for the drug in Europe.
The FDA panel was primarily concerned that Acomplia increased incidents of suicidal behavior and depression among patients. That's likely to play a major role in influencing the agency's final decision on Acomplia. It wasn't a big leap for investors to make. They sent shares of Sanofi down 8 percent on the news.
- see the release [1] on the FDA' s decision
- read the Dow Jones report [2]
Related Articles:
Sanofi shares slide as FDA delays Acomplia-again. Report [3]
Sanofi shares slip on Acomplia delay. Report [4]
Delays forecasted for blockbuster obesity drug. Report [5]
Links:
[1] http://www.fiercebiotech.com/node/7251
[2] http://money.cnn.com/news/newsfeeds/articles/djf500/200706140820DOWJONESDJONLINE000646_FORTUNE5.htm
[3] http://internal.fiercemarkets.com/cms/gamma/Sanofi%20shares%20slide%20as%20FDA%20delays%20Acomplia--again
[4] http://www.fiercebiotech.com/story/sanofi-shares-slide-on-acomplia-delay/2006-02-21
[5] http://www.fiercebiotech.com/story/delays-forecasted-for-blockbuster-obesity-drug/2006-11-01