A Food & Drug Administration panel will consider loosening the restrictions on the number of patients that can receive gastric band surgery in order to lose weight.
In a report issued ahead of a Dec. 3 meeting of its Gastroentology and Urology Devices Advisory Panel, the FDA concluded that Irvine, Calif.-based Allergan Inc. (NYSE:AGN) had proved in a three-year clinical study that its Lap-Band device showed “a significant decrease in all measures of weight loss.”
Further, the committee said (PDF) it will consider whether or not the procedure, which involves placing a permanent implant around the upper portion of the stomach to reduce the amount of food than can be ingested, should be opened up to a wider patient populations. Gastric bands are considered less invasive than stomach stapling or gastric bypass surgery.
Currently the device, which was first approved by the FDA in 2001, is indicated for use only in patients categorized as “severely obese” with a Body Mass Index or BMI of 40 or are 100 pounds or heavier than their estimated ideal weight. Allergan would like to have patients with BMI’s as low as 30 to be able to have the procedure if they’re suffering from conditions such as diabetes and hypertension.
About 220,000 people in the U.S. underwent weight-loss surgery last year, according to the American Society for Metabolic & Bariatric Surgery. However, an expanded indication opens up a vast number of new patients. For example, a 6-foot tall man weighing 220 pounds has a BMI of 30, potentially making him eligible for the surgery.
Bloomberg News Service, citing Louise Chen, an analyst with Collins Stewart LLC in New York, said Allergan could see a significant increase in sales from the expanded indication, particularly by targeting the adolescent market. Chen estimated sales could increase some 51 percent to $390 million by 2016, or $500 million if the economy improves.
The panel said Allergan had proved in clinical studies that the device was both effective and safe.
Three-year clinical studies by the company of 299 patients showed that 20 percent of the patients lost at least 50 percent of their excess weight by three years. And while 89 percent of respondents reported some adverse events, the highest number of incidents were vomiting/nausea and GE Reflux. A total of 26 patients required re-operation over the three-year study. Two patients died during the study, although the FDA did not cite the procedure as contributing to their deaths.
Click here to calculate your BMI to see if you’d qualify for gastric band surgery under new indications.
