FDA Advisory Committee votes in favor of expanded use of LAP-BAND gastric band

Dec 4 2010

Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the LAP-BAND® System, Allergan's gastric band, on the basis of a favorable benefit-risk profile for weight reduction in obese adults who have failed more conservative weight reduction alternatives and have a Body Mass Index (BMI) of at least 35 or a BMI ≥30 and at least one comorbid condition.

“Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful.”

"We are pleased with the Committee's decision, which reflects consensus that there is a need for additional, effective treatment options for patients who are currently obese, given the known significant health ramifications of obesity," said Frederick Beddingfield, M.D., Vice President of Clinical Research and Development for Allergan, Inc. "Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful."

The Committee's decision followed a review of the currently unmet clinical needs among the obese patient population, as well as 12-month data from a prospective, single-arm, non-randomized, multi-center five-year study involving 149 obese patients, who on average had been obese for 17 years, treated with the LAP-BAND® System, numerous publications, and the more than 17-year safety and effectiveness record of the LAP-BAND® System.

Currently, over 64 million Americans are obese, and of those Americans, approximately 27 million of them have a BMI of 30-35 and at least one comorbid condition. In addition, obesity is the second-leading cause of preventable death in the United States, second only to smoking. Given its known correlation to life-threatening diseases, 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. Indeed, medical research has found that if left untreated those individuals who are currently obese will likely remain obese. In addition, a preponderance of data, published literature and scientific research have found that diet and exercise succeed in only 15-20% of patients at one year, underscoring the unmet clinical need among obese patients for the availability of effective treatment options.

SOURCE Allergan, Inc.