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FDA panel to reconsider approval of weight-loss drug

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The FDA Endocrinologic and Metabolic Drugs Advisory Committee will review again today the safety and efficacy of extended-release combination phentermine plus topiramate for weight loss.

The drug (Qnexa, Vivus) is indicated as an adjunct to diet and exercise for weight management in patients with a BMI of 30 or a BMI of 27 with weight-related comorbidities, such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

In July 2010, the panel voted 10-6 against recommending approval, and the FDA Division of Metabolism and Endocrinology Products rejected approval and issued a complete response letter in October 2010. Although combination phentermine plus topiramate met the two efficacy benchmarks, the agency said, the adverse effects associated with the drug, particularly cardiovascular events and risk for teratogenicity, required further study.

The company resubmitted the new drug application for combination phentermine plus topiramate in October 2011 with additional materials, including final results from a phase 3, 1-year study of eligible patients, a CV risk analysis report and a review of the drug’s teratogenic potential.

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