FDA Advisory Recommends Approval of Obesity Medication Qnexa
After an intense day of deliberations earlier this month, an FDA advisory committee delivered an overwhelmingly positive vote (20-2) in favor of the approval of Vivus’ Qnexa for the treatment of obesity. The FDA now has until April 17 to consider the panel’s recommendation and to make a final decision on whether to approve Qnexa or ask for additional data. While approval is by no means guaranteed, the outcome of the panel looks very good for Qnexa. No other obesity drug has received such strong endorsement from an advisory committee in nearly 15 years (the last time was the unanimous recommendation to approve Roche’s Xenical in 1997). Members of the committee agreed that Qnexa works very well – in a one-year trial, participants taking Qnexa averaged weight loss of approximately 25 pounds; while those taking placebo also lost weight, it was much less, relatively speaking.
While panelists initially expressed greater concern about the potential long-term safety issues associated with the drug, including the risk of birth defects (especially cleft lip or cleft palate), and cardiovascular risk (due to the slight increase in heart rate), they were clearly reassured by the end of the meeting that the benefit/risk clearly worked in patients’ favor to recommend approval. While the FDA decided not to approve Qnexa in its first review in 2010 (see our NewNowNext in diaTribe #26 or click here for a timeline of our coverage of Qnexa over the past two years), clearly the panel felt obesity was a major health risk and that patients needed an effective medical alternative to “Weight Watchers and bariatric surgery”. Overall, panelists expressed strong reassurance that the potential risks could be reduced through what is called a Risk Evaluation and Mitigation Strategy (REMS), through which Vivus would provide education to patients, physicians, and pharmacists on the appropriate use of the drug and its associated risks, have measures in place to restrict the drug’s use only to approved types of patient, and be able to closely monitor the drug’s safety. The exact REMS has yet to be finalized, but will be a focus of conversations between Vivus and the FDA leading up to Qnexa’s potential approval date.
Panelists also were comfortable that Vivus could conduct an “outcomes” trial to better understand cardiovascular risk after it was approved, rather than before (which would mean a long delay or that development of the drug would stop altogether). They acknowledged that there is inherent harm in doing nothing to make treatment options available, which should be balanced against the risks. This is an encouraging sign that obesity may finally be coming closer to being recognized as on par with other diseases, worthy and in great need of additional treatment options. At the panel, diaTribe editor Kelly Close had the opportunity to speak on behalf of diaTribe during the open public hearing session. To see Kelly’s comments on how important the day’s decision would be for obese individuals and for companies working to develop new treatments, please click here. To view her PowerPoint presentation, please click here. –VW