Obesity Science Board Meeting Could Include Comparisons Of Marketed Drugs
This article was originally published in The Pink Sheet Daily
Executive Summary
Discussion topics for the April 22 FDA meeting include cardiovascular endpoints and a revision of a 1996 draft guidance for weight control agents.
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Cardiovascular endpoints and head-to-head comparisons of marketed obesity drugs are likely topics for the April 22 meeting of FDA's Science Board. The Science Board will discuss the agency's Obesity Working Group report, which includes a recommendation that FDA hold an advisory committee meeting to discuss existing drug therapies for obesity. The committee should "address challenges, as well as gaps in knowledge, about existing therapies (i.e. head-to-head comparisons of marketed drugs, cardiovascular endpoint studies)," the March 12 OWG report states. Three drugs have been approved by FDA for long-term treatment of obesity: Roche's Xenical (orlistat), Abbott's Meridia (sibutramine), and Wyeth's Redux (dexfenfluramine). Redux was withdrawn in 1997 for safety reasons. The report also concurs with FDA's current efforts to draft a guidance on obesity drug development. The Clinical Evaluation of Weight-Control Drugs draft guidance was last revised in 1996. U.S. obesity-related medical expenditures totaled $75 bil. in 2003, according to a recent Centers for Disease Control/RTI International study published in the January issue of Obesity Research. However, the OWG report estimates the total economic impact of obesity at up to $117 bil. per year. FDA's role in guiding appropriate use of weight loss drugs was addressed at the Oct. 23 public meeting on obesity, hosted by the OWG. FDA said the April 22 date is tentative. The OWG report is also a likely discussion topic for the Endocrinologic & Metabolic Drugs Advisory Committee, which is tentatively scheduled to meet April 22-23 and June 22-23. [Editor's note: To watch a webcast of this meeting, visit 1 FDAAdvisoryCommittee.com] - Lee Szilagyi |