The Qnexa Vote: Beyond the Bean Counting
This article was originally published in RPM Report
Executive Summary
FDA's Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus' weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.