Vivus Inc. (VVUS) said that the FDA advisory committee has voted against the approval of Qnexa for the treatment of obesity.
The FDA will take the committee's recommendation into consideration during its review of the current application and will make a determination. The FDA is expected to make a final decision on Qnexa by October 28, 2010.
In clinical studies, Qnexa has shown to reduce body weight by 10% to 15% over a year, besides improving cardiovascular and other obesity-related risk factors and even reducing sleep apnea (sleep disorder).
The FDA benchmark requires only at least a 5% weight loss in one third of study group.
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