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FDA Advisory Committee Recommends Approval of Weight-Loss Drug Contrave

After a day of deliberation earlier this month, a recent FDA advisory committee voted 13 to 7 to recommend approval of Contrave, a novel weight-loss drug made by Orexigen. The FDA now has until the end of January to make a final decision on whether to approve the drug or ask for additional data. Contrave is the third obesity drug to face the FDA advisory panel in the past six months but the first to receive a positive nod from the committee in over 10 years – a remarkable statistic, given the obesity epidemic. The other two drugs (Lorqess and Qnexa) were both voted down due to various safety concerns and have since received negative decisions from the FDA, which requested additional analyses of data for Qnexa and additional animal studies for Lorqess. The outcome of the Contrave panel was a pleasant surprise and represented a shift in opinion among the panelists. For the first time in recent history, members of the committee referenced the need for therapies that target obesity and obesity-related conditions, such as high blood pressure, high cholesterol, and type 2 diabetes (all three obesity drugs have demonstrated glucose-lowering effects). During the committee's discussion about Contrave, the primary concerns were related to the drug's tendency to marginally increase heart rate and blood pressure, compared to those taking a placebo pill. The panelists voted 11 to 7 to recommend requiring a dedicated cardiovascular "outcomes" study following FDA approval, rather than requiring it prior to approval, which would delay Contrave by at least two years. (An "outcomes" study would be a human trial that determines the long-term risk of the drug on the heart.) Going forward, the FDA will review the votes and discussion of the Advisory Committee members before making a final decision on whether to approve Contrave (expected by January 31, 2011).  --ST

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