The US 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 Allergan's gastric band LAP-Band System.
Allergan said the approval of the LAP-Band System extended use was 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.
The LAP-Band System study, initiated by Allergan, is conducted under an FDA-approved investigational device exemption (IDE) 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 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.
Allergan Clinical Research and Development vice president Frederick Beddingfield said they 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.
"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," Beddingfield said.