FDA says Lap-Band effective in less obese population
FDA said the Lap-Band adjustable gastric binding system from Allergan Inc. (NYSE:AGN) produced significant decreases in all measures of weight loss in a less obese population than that of its approved indication. The comments came in briefing documents posted ahead of Friday's Gastroenterology and Urology Devices Panel to discuss an application to expand Lap-Band's use to patients with a BMI of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more co-morbidities. FDA noted safety findings in the less obese population were similar to or better than those in patients with a BMI greater than 40 kg/m2. Lap-Band is already approved for use in patients with a BMI of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbidities. Allergan was up $0.19 to $66.46 on Wednesday. ...