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GEN News Highlights : Apr 4, 2012

2-to-1 Majority of Respondents to a GEN Poll See Smooth Sailing Ahead for Vivus' Obesity Therapy

By a greater than 2-to-1 majority, GEN readers predict FDA will approve without further clinical investigation the weight-loss drug Qnexa, which faces an April 17 deadline for action by the agency. Most respondents (65.3%) predicted FDA will approve Qnexa, while 27.2% anticipate an FDA rejection, and 7.5% were undecided.

Qnexa’s developer Vivus received welcome news on February 22 when an FDA advisory committee voted 20 to 2 in favor of the drug, concluding that its weight loss benefits outweighed its potential risks. That’s a change from 2010, when the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against FDA approving the drug due to side effects that included serious birth defects and heart problems. Since then, Vivus conducted a one-year clinical trial with new data, while only 12 holdovers from the 2010 panel remain on the current advisory committee. FDA is expected to assuage lingering concerns by asking for a post-approval cardiovascular outcomes study.