When the Endocrinologic & Metabolic Drugs Advisory Committee voted against approval of Vivus Inc.’s weight loss therapy Qnexa (topiramate/phentermine) in 2010, several panelists said they wanted the product available but only via some kind of a “staged launch.”
Setting the Stage: Qnexa and the Power of REMS
Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.
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