Allergan Inc. won a U.S. panel’s backing to market its Lap-Band weight-loss device to a greater number of obese people than it now treats.
The Lap-Band worked well enough in studies to outweigh potential risks, outside advisers to the Food and Drug Administration said today in an 8-2 vote in Gaithersburg, Maryland. The FDA usually follows the recommendations of its advisory panels.
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, is seeking to sell the Lap-Band for obese people with lower body mass indexes than the “severely” obese for whom the FDA approved the device in 2001.
“I don’t think the experience with this device will be radically different” than it has been with severely obese patients, panelist Steven Schwaitzberg, chief of surgery at Cambridge Health Alliance in Boston, said after the vote.
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 illnesses such as diabetes, heart disease and cancer, as obese people carry almost $1,500 more in yearly medical expenses, the Atlanta-based Centers for Disease Control and Prevention said in a report in August.
“The need for effective obesity treatments has never been greater,” Frederick Beddingfield, Allergan’s vice president for clinical research, said in testimony to the committee. The Lap-Band has been implanted in 600,000 people worldwide, and the device’s effectiveness and safety “have continued to improve since it was initially introduced,” he said.
Allergan rose $2.20, or 3.2 percent, to $71 at 5:52 p.m. in extended trading after gaining 52 cents to close at $68.80 on the New York Stock Exchange. The stock has climbed 9.2 percent this year.
Safety concerns have been a hurdle for drug companies seeking to introduce the first prescription anti-obesity medicine in more than a decade. Arena Pharmaceuticals Inc.’s lorcaserin and Vivus Inc.’s Qnexa failed to win clearance from the agency in October. Orexigen Therapeutics Inc.’s new diet pill Contrave has safety risks and unclear benefits, FDA staff said today in a report. The agency is scheduled to rule on that drug by Jan. 31.
Abbott Laboratories’ 13-year-old weight-loss drug Meridia was pulled from the market in October after being linked to heart attacks, strokes and deaths. Safety issues also prompted the withdrawals of Wyeth’s fen-phen in 1997 and Sanofi-Aventis SA’s rimonabant in 2007.
Allergan’s obesity products generated $258 million in revenue last year, mostly from Lap-Band sales. The device competes with a gastric band called Realize sold by New Brunswick, New Jersey-based Johnson & Johnson, the world’s largest health-care products company.
Approval of the Lap-Band for wider use may help boost Allergan’s 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 declines and consumer spending rises, she said.
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.
In Allergan’s study of that patient population, 80 percent of trial participants lost at least 10 percent of their total body weight within a year, and two-thirds lost at least 15 percent, Robert Michaelson, a surgeon at Northwest Weight Loss Surgery in Everett, Washington, said in testimony to the panel.
“This is remarkable,” said Michaelson, who has done more than 1,400 gastric banding procedures and was an investigator in Allergan’s trial. “This is a patient population who has been obese for more than a decade and they’ve tried and failed numerous methods of non-operative weight loss.”
While Allergan compensated Michaelson for today’s appearance before the FDA panel, he doesn’t have any other financial ties to the company.
Studies haven’t been conducted to determine the Lap-Band’s long-term benefits and risks, said Diana Zuckerman, president of National Research Center for Women & Families, a Washington-based advocacy group that opposes expanded use of the device.
“We don’t know whether Lap-Bands deteriorate in the body; we don’t know whether aging Lap-Bands will cause more serious health problems,” Zuckerman told the panel. “We don’t even know if the weight stays off in the long term.”
FDA clearance of the Lap-Band for more patients may “help reinvigorate a struggling franchise,” Gary Nachman, an analyst with Susquehanna Financial Group in New York, said Dec. 1 in a research note. “Sales of Lap-Band have been relatively stable in recent quarters, but they are still below their peak as a difficult economy and share losses to J&J’s Realize band have taken a toll.”
Allergan also is seeking FDA approval to market the Lap-Band to obese adolescents. The agency hasn’t yet scheduled an advisory panel meeting on that proposal. Allergan acquired the product in 2006 with its purchase of Inamed Corp.