Vivus to Resubmit Weight-Loss Drug Qnexa to the FDA

In exciting news, Vivus announced that it intends to resubmit its weight-loss drug Qnexa to the FDA for review by the end of October. As a reminder, in October 2010, the FDA chose not to approve the medication because of concerns over potential long-term safety issues, including increased cardiovascular risk (due to a slightly increased heart rate with Qnexa) and teratogenicity (risk for birth defects). For more details on the FDA’s decision, please see our NewNowNext in diaTribe #26. Following recent discussions with the FDA, Vivus and the agency have agreed on a plan that will allow the company to resubmit the drug for approval in men and women without child-bearing potential who are either obese or overweight with one or more comorbidities (i.e. diabetes, high cholesterol, high blood pressure) – an estimated 80 million adults in the US. The FDA will host a meeting in early 2012 to discuss the benefits and risks of Qnexa in this population, and is expected to make a decision on whether or not to approve the drug by April 2012. Meanwhile, an assessment of the birth-defect risk of topiramate (one of the two components of Qnexa) is ongoing; if the results show no increased risk, Vivus plans to resubmit Qnexa to the FDA in late 2012 for approval in a much larger population of people, which will include women of child-bearing potential. We view this news as encouraging. While diet and exercise should remain core to weight management, medications like Qnexa could become important tools for those struggling to manage their weight through lifestyle efforts alone. --VW