Monday, January 23, 1995
By Kris Herbst
SILVER SPRING, Md. - An FDA advisory panel on Friday recommended that proposed FDA guidance for clinical trials of weight-control drugs be relaxed, and that the label for approved weight control drugs be restricted to claims for weight loss.
The decision of the Endocrinologic and Metabolic Drugs advisory committee was hailed by Interneuron Pharmaceuticals Inc. (IPIC), which filed an NDA for dexfenfluramine as a treatment for obesity in 1993. The advisory committee's decision is "extremely positive for Interneuron," said Glenn Cooper, president and CEO. As proposed, the FDA's guidelines would force the company to return to the clinic for another year.
A majority of the panel members rejected clauses in the guidelines stipulating that efficacy trials must be at least two years, and that weight control cannot be the sole primary end point of a study.
The FDA's proposed list of acceptable primary end points includes prevention of diseases such as cardiovascular disease, diabetes and hypertension, or reduction of risk factors such as lipemia or glucose intolerance. However, the guidelines also say "reduction in weight is not, by itself, adequate demonstration of efficacy."