Tags: fda | vivus | obesity | weight-loss | qnexa

FDA Delays Ruling on Vivus Weight-loss Drug Qnexa

Monday, 09 Apr 2012 06:03 PM

Vivus Inc. said U.S. regulators delayed their decision date on whether to approve the obesity pill Qnexa by three months to July 17.

The date was extended after Vivus submitted, at the Food and Drug Administration’s request, a risk evaluation and mitigation strategy, the company said Monday in a statement. The strategy is based on discussions with the agency after advisers voted Feb. 22 in favor of the medication, while raising concern that the drug may potentially contribute to heart risks and birth defects.

The extension is standard to provide time for a full review, Vivus said. The Mountain View, California-based company is competing with Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc. to bring the first weight-loss drug to market in 13 years.

“The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February,” Leland Wilson, chief executive officer of Vivus, said in the statement. “We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans.”

Vivus declined 6.2 percent to $21.50 in extended trading at 5:22 p.m. New York time after gaining 1.7 percent to $22.92 at the close.

Qnexa raised patients’ heart rate in clinical trials and caused oral cleft palates in some fetuses of mothers who took the drug. The pill is a combination of the appetite suppressant phentermine and topiramate, an antiseizure and migraine drug.

The company submitted its risk mitigation plan on April 4, Vivus said in its statement.

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