IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (NYSE:AGN - News) 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.
“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.12 In addition, obesity is the second-leading cause of preventable death in the United States, second only to smoking.3 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.4 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.56
The LAP-BAND® System study, initiated by Allergan, Inc., is a prospective, single-arm, non-randomized, multi-center five-year study conducted under an FDA-approved Investigational Device Exemption (IDE G070039; registered at www.clinicaltrials.gov, registration # NCT00570505). The study was conducted to determine the safety and effectiveness of the LAP-BAND® System as a treatment for obesity in adult patients with a BMI of = 30 and < 40, with and without comorbid conditions. The study was initiated in 2007, and included 149 patients who underwent the LAP-BAND® System procedure. The 12-month primary endpoint data was presented at Committee today, along with relevant two-year data requested by the Agency.
The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month timepoint, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL). Percent excess weight loss (%EWL) is defined as the percent of “excess weight” – i.e., the weight above ideal weight – that is lost. Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their EWL at the one-year timepoint, more than twice the percentage required for success. More than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study. This level of weight loss exceeds what is typically seen with more conservative treatment, such as diet and exercise.
The secondary endpoints for the trial were improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension and improvement in Quality of Life (QoL). Eighty five percent of subjects in the trial had at least one comorbid condition. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22-33% of patients with those conditions, their conditions resolved after one year. In addition, approximately 60% of patients, who had a comorbidity at baseline, had improvement of at least one comorbid condition by month 12. Also, there was a statistically significant improvement in QoL at months six and 12.
During the 12-month study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than 4 weeks.
The LAP-BAND® System was originally approved by the FDA 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. In addition, the LAP-BAND® System has been approved internationally since 1993. Over the past 17 years, more than 600,000 procedures have been performed, leading to over two million patient years of exposure for the device.
Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient's ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.
CAUTION: Rx only.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements by Dr. Beddingfield, and other statements regarding the safety, effectiveness, adverse reactions, product availability and market potential of the LAP-BAND® System. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2009 Form 10-K and Allergan's Form 10-Q for the quarter ended September 30, 2010. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.Allergan.com or you can contact the Allergan Investor Relations department by calling (714) 246-4636.
About Allergan, Inc.
Allergan, Inc. is a multi-specialty health care company established 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 9,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
