This article was originally published in RPM Report
Sanofi's Acomplia fit all the criteria for an advisory committee review. But despite some safety concerns, FDA had good reasons not to hold one.
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An FDA advisory committee's recommendation against the approval of Sanofi-Aventis' rimonabant caught many investors off guard. It's hard to believe drug safety issues can still surprise Wall Street, but there are some reasons why analysts lacked clarity on rimonabant.
Rimonabant had all the early signs of a mega-blockbuster. But behind that shiny veneer was a drug with a serious risk profile-one that mimicked the suicidality rates of the SSRI class. That made rimonabant an enormous red flag for FDA reviewers. Why didn't Sanofi-Aventis see it coming?
Sanofi-Aventis' investigational weight loss drug rimonabant will be the subject of a high-profile advisory committee review smack in the midst of a sensitive political environment for FDA. But even if Sanofi manages to eke out an approval, it will face yet another marketing challenge: the loss of the well-recognized brand name Acomplia.