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Setting the Stage: Qnexa and the Power of REMS

 
• By Michael McCaughan

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.

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.”

When the same committee voted overwhelmingly to approve the product on the second go-around February 22, it was largely because the committee members felt they would get exactly that, in...

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