WEIGHT LOSS ALONE APPROPRIATE AS PRIMARY ENDPOINT IN OBESITY STUDIES, FDA CMTE. SAYS; ONE-YEAR EFFICACY AND TWO-YEAR SAFETY DATA NECESSARY FOR APPROVAL
Weight loss alone is an appropriate endpoint in clinical trials for products that will be used in long-term therapy for obesity, FDA's Endocrinologic & Metabolic Drugs Advisory Committee decided Jan. 20. The committee voted 7-3 that clinical efficacy shown in weight loss is sufficient for approval of anti-obesity drugs.
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