The Food and Drug Administration said Wednesday that Lap-Band, a weight loss device from Irvine-based Allergan Inc., is effective for treating more obese people than it’s now approved for.
Clinical trials showed that the adjustable silicon stomach band improved health-related quality of life in people who aren’t as heavy as current users, according to regulators.
A FDA report showed that no deaths or “unanticipated adverse effects” occurred with the device.
Allergan is looking to sell Lap-Band for treating people who have a body mass index of 35 or even 30 for those with other complications.
Lap-Band is now approved for people who have a body mass index of at least 40, or 35 in conjunction with other problems such as diabetes.
If the FDA signs off on Allergan’s request, the device could become available to a 5-foot-9-inch man who weighs 203 to 236 pounds, compared with a current minimum of 270 pounds for that height.
A group of FDA advisers are set to meet Friday to evaluate the findings and vote on whether the benefits of expanded Lap-Band use could outweigh potential risks.
Earlier this year, Allergan conducted a public relations campaign aimed at getting wider acceptance and insurance coverage of Lap-Band.
Allergan got the device through its buy of Inamed Corp. in 2006.
