FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

Dec 8 2010

The Obesity Action Coalition (OAC), The Obesity Society (TOS) and the American Society for Metabolic and Bariatric Surgery (ASMBS) found encouragement in the outcome of today's advisory committee hearing, favoring approval for the first new obesity treatment in more than 10 years.

Today, the FDA Endocrine and Metabolic Advisory Panel voted 13-7 for approval for Contrave, a new treatment for obesity. In response to these decisions, Joe Nadglowski, OAC President and CEO said, "The OAC is encouraged because this is the first indication in some time that a new treatment can receive a favorable hearing from FDA. Treating obesity is a complex problem requiring many tools in the toolbox."

Jennifer Lovejoy, Ph.D., President of TOS, commented, "The FDA Advisory Panel carefully weighed the research evidence in reaching this decision, and laid out future research needs.  Today was a good example of how the FDA can balance risks and benefits in reviewing new treatments."

Said Bruce Wolfe, MD, FASMBS, President of the ASMBS, "The federal government and medical experts agree that obesity is the single biggest threat to America for the coming century, and the FDA can be part of the solution. We support Friday's decision on expanded indications for gastric banding, and we call on the FDA to adopt a comprehensive approach and define a clear path for innovation in all forms of treatment of this disease."

Earlier this year, the FDA has held hearings on three obesity drugs in quick succession, with negative results for every treatment under review. In each of the hearings, Nadglowski noted, "We, as a society, must gain control of the obesity epidemic and begin helping those affected; however, we will continue to watch this epidemic spiral out of control if we do not address it with a multitude of treatment options, including effective pharmaceutical agents."

In a recent study, the costs related to treating obesity-related medical conditions were reported to be $168 billion dollars, representing 17 percent of total medical costs in the U.S.  Research has clearly documented the harmful health effects of excess body weight, which increases risk for conditions including diabetes, hypertension, sleep apnea, hip and knee arthritis, low-back pain, and depression.  Importantly, many of these weight-related conditions are significantly improved by weight losses of as little as 5-10% of total body weight.

"We greatly hope that the FDA will continue working with the pharmaceutical industry and utilize a fair and balanced approach moving forward weighing the well-documented benefits of treating obesity against the risks associated with any medication developed for the treatment of obesity. We are at a crucial crossroad where the time to develop safe and effective treatment options for those affected by the disease of obesity is now," said Nadglowski.