Obesity Care Continuum Liraglutide Testimony to FDA Endocrinologic and Metabolic Drugs Advisory Committee
September 11, 2014
Oral remarks offered by Domenica Rubino, MD, member of The Obesity Society:
My name is Dr. Domenica Rubino and I am the Director of the Washington Center for Weight Management and Research in Arlington, Virginia. I am currently a site Investigator for Novo-Nordisk clinical trial 1839 (which examines impact of liraglutide on pre-diabetes). I am here at my own expense. As a member of The Obesity Society, I am pleased to present the views of the Obesity Care Continuum or “OCC” during today’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee regarding the safety and efficacy of new drug application (NDA) 206321 for Liraglutide an injectable therapeutic for obesity.
Established in 2011 the OCC currently includes the Obesity Action Coalition, The Obesity Society, the Academy of Nutrition and Dietetics, the American Society for Metabolic and Bariatric Surgery, and the American Society of Bariatric Physicians. With a combined membership of over 125,000 healthcare professionals, researchers, educators and patient advocates we are dedicated to promoting access to, and coverage of, the continuum of care surrounding the treatment of the person with overweight and obesity.
The OCC has been pleased with the tremendous progress made by the FDA throughout the last two years in its review and approval process for new obesity therapeutics. We are excited about FDA’s approval of three new drugs for the treatment of the disease of obesity the third drug approval yesterday.
But it is important that we maintain focus on the overarching goal: We need more options as adjuncts to our medical & surgical approaches for obesity treatment. We all agree that the treatment of obesity is complex, with many contributors, such as genetic, emotional, environmental, physical, behavioral and the physiologic protection against weight loss, which we are only beginning to understand. Additionally, there are individual responses to the various treatments we have. For these very reasons, we need more FDA-approved obesity treatments to help us improve the quality of life of those who suffer from obesity.
In addition to expanding the clinical treatment options that are sorely needed, the development of new and innovative medical therapies for obesity helps researchers better understand the complicated hormonal systems of weight regulation and consequent dietary behavior. Continued advancement in medical therapeutics for the prevention and management of both obesity and type 2 diabetes is our goal.
Today, we, the OCC, strongly encourage the FDA to continue to be proactive in its evaluation of both the risks and benefits of Liraglutide. For the first time in history, we are glimpsing an emerging spectrum of tools to treat a person with obesity. It is imperative that we keep this positive energy in our move forward with the future approval of obesity treatment options to improve the feeling, form and function of those who suffer from obesity and its complications.
About the Obesity Care Continuum
The Obesity Care Continuum (OCC) was established in 2011 and currently includes the The Obesity Society, Obesity Action Coalition, Academy of Nutrition and Dietetics, the American Society for Metabolic and Bariatric Surgery, and the American Society of Bariatric Physicians. With a combined membership of over 125,000 healthcare professionals, researchers, educators and patient advocates, the OCC is dedicated to promoting access to, and coverage of, the continuum of care surrounding the treatment of overweight and obesity. The OCC also challenges weight bias and stigma oriented policies – whenever and wherever they occur.