The Fate of Vivus’ Weight Loss Drug Qnexa Rests with FDA

Just one day after the controversial meeting on Avandia, the FDA Advisory Committee met again, this time to consider the approval of a new weight loss drug named Qnexa, made by Vivus. After a short day of deliberation, the committee delivered the decision not to approve the drug, 10 to 6 – we were also at this meeting reporting, and this vote was contrary to our expectations. However, while the majority of panelists voted not to approve Qnexa, the outcome of this decision is much more nuanced than a quick glance at the vote would portray, as most panelists were self-proclaimed to be “on the fence.” Ultimately, the panel was concerned with unanswered questions about the long-term safety of the drug, primarily in the domains of cardiovascular risk, teratogenicity (the risk for birth defects), and psychiatric problems, and particularly given the large population in which the drug would likely be used. Most panelists agreed that they would like to see more data, although there was clear indecision over the question if the data was needed before or after the drug was approved. Overall, it is clear this panel would have been more comfortable with a much more restricted label and the two-year data that Vivus plans to submit to FDA (only one-year data was available to the panel at the time of their meeting, though we note that current FDA guidelines suggest only one year of efficacy and safety data is necessary to approve a weight loss drug). We are eager to see what the FDA’s final decision on the drug will be, as the advisory committee’s vote is only a recommendation, albeit one that the FDA rarely goes against – we would not expect the FDA to go against the panel in this case, given the current highly politicized environment. Please see New Now Next in diaTribe #21 for more information about Qnexa’s notable effects on weight loss. Because patients and providers need alternatives, we hope for approval with restrictions on who can use the drug while more data is amassed. --JS