FDA advisory committee shoots down Vivus' Qnexa

MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.

“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”

The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.

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