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Vivus, Arena Unlikely to Be Affected by FDA Obesity Panel

(Anna Edney and Catherine Larkin on March 30, 2012)

Arena Pharmaceuticals Inc. and Vivus VVUS, competing to win U.S. regulatory approval for weight-loss treatments, probably won't be affected by an advisory panel's recommendation for heart-risk studies, a Food and Drug Administration spokeswoman said.

The panel voted 17-6 yesterday in Silver Spring, Maryland, to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes. The panel's goal was to help the agency update guidelines for bringing obesity treatments to market, Erica Jefferson, a spokeswoman for the FDA, said in an e-mail today.

"It's unlikely that the discussions over the past couple days will impact any existing applications," Jefferson said.

According to this excerpt found in Bloomberg BusinessWeek dated March 30 2012, the FDA is simply updating their own guidelines, and this "should not" affect the April 17th decision of the greatly needed weight loss drug Qnexa!