DA Panel Rejects Vivus Weight-Loss Drug Qnexa
On Thursday July 15, 2010 the decision to reject Vivus Inc.’s (VVUS) experimental weight-loss drug, Qnexa was made by a U.S. federal advisory panel. The concern is safety issues and long term effects that are unknown.
The Food and Drug Administration advisory panel voted 6-to-10 against the drug. They were asked if they believed that the “overall risk-benefit assessment of Qnexa is favorable to support approval” especially in patients with obesity that might also have other health problems such as high blood pressure or diabetes.
Although the drug has resulted in significant weight loss, the agency has concerns about the long term effects including depression, the effects on the heart and birth defects. At this time there is only a year’s worth of data available on the drug.
Eric Colman, deputy director of the FDA’s metabolic and endocrinology products division, believes that not all the members of the panel were sure of their decision. The votes were 7-10 at first until there was a discussion on why the panel voted the way it did and one member then changed their vote.
Colman says that he is surprised that the votes went the way they did especially considering that both of the ingredients in Qnexa are already on the market separately in other drugs. Colman stated, “They weren’t strongly against the drug but had lingering concerns,”
DA Panel Rejects Vivus Weight-Loss