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 on the FDA' s decision
- read the Dow Jones report
Sanofi shares slide as FDA delays Acomplia-again. Report
Sanofi shares slip on Acomplia delay. Report
Delays forecasted for blockbuster obesity drug. Report