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Diet drugs not shaping up; UAB doc says it could be a loss for patients

Posted Oct 29 2010 12:00am

Another potential obesity drug fails to gain federal approval, which could cause pharmaceutical companies to rethink their commitment to developing diet drugs, says a UAB researcher involved in the clinical trials of Qnexa. The FDA yesterday rejected Qnexa, which some experts considered the most promising obesity drug developed in the past decade.

As quoted in the New York Times Friday, Tim Garvey, M.D., chair of the UAB Department of Nutrition Sciences , said, “It’s going to put the brakes on all obesity drug development for a decade.”

In a separate interview with the Associated Press , Garvey said, “Why would a company put all that investment into developing a drug if the FDA signals they aren't willing to approve it.”

Garvey conducted two clinical trials of Qnexa at UAB and served as a consultant for its manufacturer, Vivus. According to a statement from Vivus, the FDA asked for more information on its possible health risks, particularly for cardiovascular events and risks for women of childbearing age.

It’s been a rough stretch for obesity drugs. The FDA also rejected a drug called lorcaserin last week, citing safety concerns, and early in October demanded the recall of Meridia, in use for years, because of evidence of increased risk for heart attack and stroke. Another diet drug, Contrave, goes before the panel soon. As Garvey points out, it could bring obesity drug development to a screeching halt if that drug fails to win FDA approval, which does not bode well for a state such as Alabama, sitting squarely in the gut of the Fat Belt.

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