Allergan Inc.’s (NYSE:AGN) Lap-Band gastric banding device won a nod from a Food & Drug Administration advisory committee for use on less-obese patients.
The Gastroentology and Urology Devices Advisory Panel, which provides recommendations to the watchdog agency on product approvals, voted 8-2 that the FDA allow doctors to prescribe the Irvine, Calif.-based company’s device for patients with a body mass index of at least 35, or a BMI greater than or equal to 30 along with at least one co-morbid condition, such as diabetes or hypertension.
"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," Allergan vice president of clinical research and development Dr. Frederick Beddingfield said in prepared remarks.
The procedure involves placing a permanent implant around the upper portion of the stomach to reduce the amount of food than can be ingested. Gastric bands are considered less invasive than stomach stapling or gastric bypass surgery. The FDA panel felt that the benefits of extending use of the device to healthier patients outweighed its risks.
The device, first approved by the FDA in 2001, is indicated for use only in patients categorized as “severely obese,” with a BMI of 40 or 100 pounds or more over their estimated ideal weight.
The agency concluded in a Dec. 3 report that Allergan had proved in clinical studies that the Lap-Band showed “a significant decrease in all measures of weight loss.”
The 299-patient study showed that 20 percent of patients lost at least 50 percent of their excess weight after 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 subjects died during the study, although the FDA did not cite the procedure as contributing to their deaths.
Allergan could see a significant increase in sales from the expanded indication, particularly by targeting the adolescent market, Collins Stewart LLC analyst Louise Chen told the Bloomberg news service. Chen estimated that sales could increase some 51 percent, to $390 million, by 2016, or $500 million if the economy improves.
Click here to calculate your BMI to see if you’d qualify for gastric band surgery under the new indications.
