FDA approves expanded use of Lap-Band system
By AMANDA PEDERSEN
Medical Device Daily Senior Staff Writer
Roughly 37 million more Americans are now eligible for weight loss surgery with the Lap-Band adjustable gastric banding system, Allergan (Irvine, California) reported. The FDA has approved the expanded use of Allergan's Lap-Band system 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 to 40 and at least one obesity related co-morbid condition.
According to the company, nearly 37 million Americans have a BMI of 30-40 and at least one co-morbid condition. Those numbers underscore the fact that obesity is a growing health epidemic in the U.S. and the need for additional effective treatment options, Allergan said.
"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, MD, Allergan's VP of clinical R&D. "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."
Allergan notes that obesity is the second-leading cause of preventable death in the U.S., second only to smoking.
Cathy Taylor, an Allergan spokeswoman, told Medical Device Daily that the expansion of the Lap-Band system will be a long-term growth driver. "It's important to understand that currently approximately 15 million people in the United States qualify for weight loss surgery, but in 2009 about 220,000 weight loss surgery procedures were done. This low number of procedures is due to several factors: lack of acceptance among obese that diet and exercise alone will not be enough and they need to speak with a physician about weight loss surgery options; [and] societal stigma against the obese that excess weight is a personal choice or lack of will power," Taylor said. "So, understanding all of the above, even with our label to expand to enable more people to qualify for surgery, doesn't mean we are going to see an immediate impact on sales given the above external factors facing the business."
After an FDA panel recommended approval to extend the Lap-Band use late last year (Medical Device Daily, Dec. 7, 2010), analysts with Millennium Research Group (Toronto, Ontario) estimate that Allergan will lead the market over its closest competitor, Ethicon Endo-Surgery (Cincinnati), with an 80% market share compared to its current 70% market share (MDD, Dec. 22, 2010). Ethicon develops the Realize adjustable gastric band.
The approval to expand the use of the Lap-Band 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 device. 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 Database (BOLD). 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 co-morbid conditions observed in Lap-Band patients over the course of 10 years, the company said.
Given its known correlation to life-threatening co-morbid conditions, such as heart disease, stroke, Type II 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, the company said. 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% to 85% of patients at one year, the company added.
"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, MD, PhD, 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 Lap-Band system study, initiated by Allergan, was conducted under an FDA-approved investigational device exemption to determine the safety and effectiveness of the system as a treatment for obesity in adult patients with a BMI of between 30 and 40, with and without co-morbid 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 who underwent the Lap-Band procedure.
The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month time point, where clinically meaningful weight loss was defined as at least 30% excess weight loss (EWL). Percent EWL is defined as the percent of excess weight – 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 excess weight at the one-year time point, more than twice the percentage required for success, Allergan said. 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 obesity related co-morbid conditions of dyslipidemia, Type II diabetes, and hypertension and improvement in quality of life (QoL). The company reported that 85% of subjects in the trial had at least one co-morbid condition. In terms of improvement in co-morbid conditions of dyslipidemia, Type II diabetes, and hypertension, 22% to 33% of patients with those conditions saw their conditions resolved after one year. In addition, about 60% of patients, who had a co-morbidity at baseline, had improvement of at least one co-morbid condition by month 12. Also, there was a statistically significant improvement in QoL at months six and 12, the company noted.
During the 12-month study period, the types of adverse events reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease, the company said. Most of these events were mild to moderate in severity and resolved in less than four weeks.
The Lap-Band 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 co-morbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In addition, the system has been approved internationally since 1993. The Lap-Band is now the only FDA-approved device for bariatric surgery in patients with a BMI of 30 to 35, Allergan said. Over the past 18 years, more than 650,000 procedures have been performed, leading to more than two million patient years of exposure for the device.
Amanda Pedersen, 309-351-7774;
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