Health care company Allergan Inc. (NYSE: AGN) said the U.S. Food and Drug Administration (FDA) has approved the wider use of its Lap-Band weight-loss system for adults with obesity who have failed more conservative weight-loss therapies and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition.
Although this label expansion represents a significant advancement in obesity treatment, the Lap-Band System is not intended for everyone, said Frederick Beddingfield, Allergan's Vice President of Clinical Research and Development.
Beddingfield said the system does represent a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option.
At present, 37 million Americans have a BMI of 30-40 and at least one comorbid condition, underscoring obesity as a growing health epidemic in the United States and the need for additional effective treatment options.
Obesity is the second-leading cause of preventable death in the United States, second only to smoking.
The Irvine-based company said the approval is based on data from a prospective, single-arm, non-randomized, multi-center five year-study to determine the safety and effectiveness of the system as a treatment for obesity in adult patients with a BMI of greater than or equal to 30 and less than 40, with and without comorbid conditions.
The study was initiated in 2007, and included 149 patients, who had a mean excess weight of 62.8 lbs and had been obese on average for 17 years and who underwent the LAP-BAND® System procedure.
FDA originally approved the system in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. Also, the Lap-Band system has been approved internationally since 1993.
The LAP-BAND system meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss, said Robert Michaelson, Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator.