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Qnexa, the new obesity drug to be reviewed for cardiovascular risks by FDA

Qnexa, the obesity drug will be reviewed for another three months, by U.S. Food and Drug Administration, for cardiovascular risks. The advisory panel for the FDA, Endocrinologic and Metabolic Drugs Advisory Committee, voted 17-6 to require obesity drugs to undergo more stringent clinical trials.

The panel made its recommendation on March 29 after a two-day discussion on the development of obesity drugs and recommendations for phase 2 and 3 clinical trials. The discussions mainly focused on results of the Look AHEAD (Action for Health in Diabetes), SCOUT and CRESCENDO trials.

“Since obesity drugs work by a wide variety of mechanisms, evaluating their effect on traditional cardiovascular risk in addition to possible effects on cardiac valves and pulmonary pressures is essential,” said William Zoghbi, MD, FACC, president of the ACC.

If approved, this drug will be the first new prescription weight loss pill to reach the market in more than a decade. The expected decision is due sometime before or on July 17.

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