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In Brief: Obesity drugs

Executive Summary

Obesity drugs: Degree of weight loss needed to show clinical efficacy for weight reduction agents will be focus of discussion at the upcoming Endocrinologic & Metabolic Drugs Advisory Committee on July 14 ("The Pink Sheet" June 12, In Brief). At its January meeting, the E&M advisory committee recommended a 5% change from baseline over a one year study to show efficacy. FDA has questions for the committee about the statistical design and analysis of studies needed to show such a difference. In its revised draft Guidance for the Clinical Evaluation of Weight-Control Drugs, the agency does not specify a degree of weight loss as a study target ("The Pink Sheet" May 1, T&G-9)...
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