GAITHERSBURG: An approved stomach band can help people who are less obese than those now considered good candidates for weight-loss surgery, maker Allergan Inc (AGN.N) told a U.S. advisory panel reviewing the device on Friday.
The manufacturer of Botox, breast implants and other cosmetic products wants approval to promote the surgically implanted Lap-Band device for people with lower body mass indexes (BMI) who are still categorized as obese. Wider approval could push sales higher from the current $182 million in the first three quarters of 2010.
Allergan told the panel people in the lower range of obesity needed an approved surgical option to help reduce the health risks of heart disease, strokes and premature death from excess weight.
"It is clear we need more options to offer patients," Dr. Caroline Apovian, an Allergan consultant and director of the Nutrition & Weight Management Center at Boston Medical Center, told a Food and Drug Administration advisory panel.
The committee of outside experts was set to vote Friday afternoon on whether to recommend FDA approval for broader use of the device, a band placed around the upper part of the stomach to create a small pouch and limit food intake.
Separately, FDA staff said an experimental diet pill from Orexigen Therapeutics (OREX.O) was effective for some patients but raised concern about its risks. An advisory panel will vote on that drug on Tuesday. [ID:nN0340431]
With the Lap-Band, Allergan wants to promote the device for adults with a BMI of 35 or higher, or at least 30 plus one weight-related health problem such as diabetes or high blood pressure. A person 6 feet (1.8 meters) tall would need to weigh about 225 pounds (102 kilograms) to have a BMI of at least 30.
The Lap-Band is already cleared for adults with a BMI of at least 40, or at least 35 plus one other health problem. About 15 million Americans are candidates under the currently approved definition and about 27 million more fit under the broader group, Allergan said.
Collins Stewart analyst Louise Chen said she conservatively estimates Lap-Band sales could rise to $390 million annually by 2016. Allergan's total annual sales for all products are around $4 billion.
For the Lap-Band, Allergan studied 149 patients in the less obese group. Nearly 81 percent of them had lost at least 30 percent of their weight at one year, and two-thirds were no longer considered obese, the company said.
No unexpected complications were reported. About 2 percent of device-related problems were severe, FDA staff said. One patient's band was removed due to erosion, while another's was repositioned in a new operation after it slipped. No patients died during the study, although death is a risk with the surgery.
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