Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BAND® System, Allergan's gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. Currently, approximately 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.
"Given the proven and significant health ramifications of obesity, we are pleased with the FDA's decision to expand the use of the LAP-BAND® System," said Frederick Beddingfield, M.D., Allergan's Vice President of Clinical Research and Development. "Although this label expansion represents a significant advancement in obesity treatment, the LAP-BAND® System is not intended for everyone. The LAP-BAND® 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."
Obesity is the second-leading cause of preventable death in the United States, second only to smoking. Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese. However, not all weight-loss treatments are effective over the long term - as a preponderance of data, published literature and scientific research have found that diet and exercise is unsuccessful in 80-85% of patients at one year.
"As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success," said Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator. "These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. 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."
The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System. Following approval, the patients in the trial will continue to be followed for a total of five years. In addition, there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal DatabaseSM (BOLDSM). Established in 2007 by the Surgical Review Corporation, BOLD is now the world's largest and most comprehensive repository of clinical bariatric surgery patient information. The database currently contains more than 300,000 patients and 12,000 new patients are added monthly. The BOLD analysis will consist of examining the explant rates, adverse events, weight loss, and changes in the status of obesity related comorbid conditions observed in LAP-BAND® System patients over the course of 10 years.
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