Allergan Inc.’s Lap-Band weight-loss device is safe and effective in more obese people than it’s now approved to treat, U.S. regulators said.
Clinical trials showed the Lap-Band improved health-related quality of life in patients who aren’t so obese as current users, the Food and Drug Administration said today. Approval would make Lap-Band available, for instance, to a 5-foot-9 inch man who weighs 203 to 236 pounds, compared with the current minimum of 270 for that height.
The adjustable silicon band helps people lose weight by reducing the amount of food their stomachs can hold. Allergan, the Irvine, California-based maker of the wrinkle smoother Botox, seeks clearance to sell the device for obese people with lower body mass indexes than the “severely” obese, whom the FDA approved the device to treat in 2001.
Surgically implanting the Lap-Band “resulted in statistically significant decreases in all measures of weight loss,” FDA reviewers said in today’s report. More than 65 percent of trial participants lost at least half their excess weight within 12 months.
About 220,000 people in the U.S. underwent weight-loss surgery last year, according to the American Society for Metabolic & Bariatric Surgery, a Gainesville, Florida-based doctors’ organization. Being overweight costs Americans as much as $150 billion a year from ills such as diabetes, heart disease and cancer, as obese people carry almost $1,500 more in yearly medical expenses, the U.S. Centers for Disease Control and Prevention, based in Atlanta, said in a report in August.
No deaths or “unanticipated adverse events” occurred with the Lap-Band, the report showed. Most side effects were mild, and “only 2.3 percent were severe,” the FDA staff said.
Outside advisers to the agency are scheduled to meet Dec. 3 to evaluate the findings and vote on whether benefits of expanded use outweigh any potential risks.
The FDA will ask the advisers to discuss whether clinical trial participants sufficiently represented patients in the U.S. who would be eligible to receive the device. Most U.S. patients in the study were white women, according to the report.
Allergan’s obesity products generated $258 million in revenue last year, mostly from Lap-Band sales. Approval for wider use may help boost sales to $390 million in 2016, Louise Chen, an analyst with Collins Stewart LLC in New York, said Nov. 30 in a research note. Revenue may climb to $500 million if unemployment decreases and consumer spending rises, she said.
Allergan rose 19 cents to $66.46 at 4:15 p.m. in New York Stock Exchange composite trading. The stock climbed 13 percent in the 12 months through yesterday.
The Lap-Band is implanted around the upper part of the stomach through laparoscopic incisions that are less invasive than gastric-bypass or stomach-stapling surgeries. The device is approved for people who are at least 100 pounds (45 kilograms) overweight, have a body mass index of at least 40, or have a BMI of at least 35 with obesity-related conditions such as heart problems.
A BMI of 40 is about equivalent to a 5-foot 9-inch (175-centimeter) person who weighs 270 pounds, according to the U.S. National Institutes of Health, based in Bethesda, Maryland. The index, used to estimate what constitutes a healthy weight based on an individual’s height, is weight in pounds times 703 divided by the square of height in inches.
The expanded use, if approved by FDA, would let Allergan market the device for patients with a body mass index of at least 35, and people with a BMI of at least 30 who have obesity-related conditions. A person who is 5 feet, 9 inches tall would weigh about 236 pounds with a BMI of 35, and 203 pounds if the BMI is 30, according to the NIH.
“The approval and launch of a new indication for Lap-Band is good” for Allergan, “but uptake may be slow given the high unemployment rate,” Chen said in yesterday’s note. The company “will also have to work with payers on reimbursement if the new indication is approved,” she said.
Allergan also is seeking FDA clearance to market the Lap-Band to obese adolescents. The agency hasn’t scheduled an advisory panel meeting on that proposal. Allergan acquired the product in March 2006 when it completed the purchase of Inamed.