Is there a path forward for FDA approval of new obesity drugs?

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An important artcile was published September 8th, 2011 on the topic of the challenges of FDA approval for new obesity drugs in the United States in the journal Current Opinion in Endocrinology, Diabetes and Obesity. Written by Obesity PPM's Chief Health Policy Officer Morgan Downey, researcher and scientific leader, Dr. Arya Sharma, and clinical leader at the Geisinger Obesity Institute, Dr. Chris Still, the paper is titled "Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?"  Click here to download the PDF.  

Purpose of reviewmeridia_image_150x150
Obesity continues to increase in prevalence in the USA and throughout the world. It is clearly a major contributor to morbidity and mortality. Unfortunately, effective prevention strategies are few. As a contributor to cardiovascular disease, obesity is an important treatment objective. However, before approval, all drugs must meet safety and efficacy concerns of the US Food and Drug Administration.

Recent findings
Since July 2010, the Food and Drug Administration’s Endocrine and Metabolic Advisory Committee has reviewed three new drug applications and one previously approved drug for the treatment of obesity. This review examines in detail the Advisory Committee’sconsideration of the risk–benefit equation of the four drugs with a concentration on sibutramine and its key study, Sibutramine Cardiovascular Outcomes Trial.

Summary
Future development of drugs for the treatment of obesity will be dependent on whetherthey can survive review for safety and effectiveness. The Food and Drug Administrationcontinues to be highly concerned with proposed obesity drugs increasingcardiovascular or any risks and may require changes to clinical research protocols.KeywordsFood and Drug Administration approval, obesity, weight loss medications