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March 20, 2012

Vivus' Obesity Drug Development

On February 22, an FDA advisory committee voted 20 to 2 in favor of Vivus’ anti-obesity drug Qnexa, concluding that its weight loss benefits outweighed its potential risks. While not bound by committee recommendations, the FDA will consider the guidance during its review, scheduled for April 2. The committee decision marked the end of a long road for Qnexa, which had been rejected by the agency in September 2010 in a 10–6 vote. The reason was not a lack of efficacy but its side effects including serious birth defects and heart problems. If the FDA green-lights Qnexa, it is expected to assuage concerns by asking for a post-approval cardiovascular outcomes study. Do you think FDA will okay Vivus’ anti-obesity treatment without further clinical investigation?

Will Vivus win approval for Qnexa as a treatment for obesity?

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