The Obesity Society (TOS) and the Obesity Action Coalition (OAC) today called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity.
On December 7, the FDA Endocrine and Metabolic Advisory will review a New Drug Application for Contrave, for the treatment of obesity. In October, the FDA rejected two other newly developed obesity treatments, Qnexa (phentermine/topirimate) and Lorquess (lorcaserin), citing safety concerns. Also in October, the FDA asked for the removal of the previously approved weight-loss drug Meridia (sibutramine) from the market due to safety concerns.
Jennifer Lovejoy, PhD, President of TOS commented, "We are deeply concerned about the effect that the FDA's recent decisions will have for on-going and future research into desperately needed new obesity treatments. As the FDA's advisors consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need."
A study published in the most recent New England Journal of Medicine provides a stark reminder that the obesity epidemic is a deadly disease. In a study of mortality in 1.46 million people sponsored by the NIH, investigators reported that weight classifications "overweight" and "obesity" are associated with significant excess mortality.
"The time for action is now," said Joe Nadglowski, OAC President and CEO. "The number of those affected by obesity is growing at an incredibly rapid rate and the millions of Americans already affected by the disease are lacking the necessary medically approved treatment and long-term options so desperately needed."
Both TOS and the OAC greatly hope that the FDA and its advisors can play a proactive and constructive role to improve this extremely serious situation. "It is imperative that the FDA review any obesity treatment presented to them with the understanding that more than 93 million Americans are depending on them for help with this disease," said Lovejoy.