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Obesity drug 5% weight loss endpoint: advisory cmte. okays multiple analytical methods.

This article was originally published in The Tan Sheet

Executive Summary

OBESITY DRUG 5% WEIGHT LOSS ENDPOINT: MULTIPLE ANALYTICAL METHODS could be considered appropriate to support efficacy, FDA's Endocrinologic & Metabolic Drugs Advisory Committee recommended at a July 14 meeting. The committee agreed that different analytical methods could be used to prove whether an obesity drug meets the endpoint criteria of a 5% greater weight loss on drug than placebo so long as the criteria are pre-defined. The discussion was a follow-up to the committee's January recommendation that FDA accept 5% weight loss at one year after initiation of treatment as a clinically meaningful obesity drug effect.

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