Allergan Inc’s already approved stomach band was effective for reducing weight in a broader group of obese patients, U.S. reviewers said in documents released on Wednesday.
The maker of Botox, breast implants and other cosmetic products wants approval to promote the surgically implanted Lap-Band device to people with lower body mass indexes who are still considered obese. Wider approval could boost sales.
Allergan shares gained 0.3 percent to close at $66.46 on the New York Stock Exchange.
In an Allergan study, “there was significant decrease in all measures of weight loss,” Food and Drug Administration reviewers wrote in a summary prepared for outside advisers who will consider the wider use on Friday.
The company is seeking FDA approval to promote the Lap-Band 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 tall would need to weigh about 225 pounds (102 kilograms) to have a BMI of at least 30.
The Lap-Band is approved 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.
The company 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, FDA reviewers said.
No unexpected complications were reported. About 2 percent of device-related problems were considered severe, FDA staff said. One patient’s band had eroded and was removed, while another’s was repositioned in a new operation after it slipped.
The FDA reviewers said they had some questions about Allergan’s data, including whether the people who were studied represented the types of U.S. patients who would be eligible if wider use is approved. Most patients studied were white women, and nonwhite men were underrepresented, they said.
Collins Stewart analyst Louise Chen said she conservatively estimates Lap-Band sales could rise to $390 million by 2016. The device, which is placed around the upper part of the stomach to create a small pouch and limit food intake, already commands two-thirds of the $300 million to $400 million gastric band market.
Wider approval would be positive for Allergan, Chen said, but “uptake may be slow given the high unemployment rate” as many patients pay out of pocket for the device.
The surgery costs between $12,000 and $20,000, Allergan said.
More than 72 million U.S. adults are obese, which raises the risk of heart disease, stroke, diabetes and some types of cancer. Efforts to fight fat with a pill have fallen short, leading some patients to consider surgical options.
Allergan dominates other markets with products such as wrinkle smoother Botox and dermal filler Juvederm, making it an attractive takeover target for large drugmakers.
The FDA cleared the Lap-Band for sale in 2001. The device can be implanted through a small “keyhole” incision. The procedure is less invasive than stomach stapling or gastric bypass, which involves cutting and rerouting the stomach. Johnson & Johnson sells a rival device called Realize.
The FDA panel is set to vote on Friday afternoon on whether to recommend approval for the less-obese patients. The agency usually follows panel recommendations.
Doctors are free to implant the Lap-Band now in any patient they consider appropriate, but Allergan needs FDA approval to market the device for the wider group.
In a summary also released by the FDA, Allergan said its study findings “make it clear that the benefits of the weight loss exceed the risk of surgery and the risk of failure to treat” obesity.
Allergan also is studying the Lap-Band in teens ages 14 to 17.
(Reporting by Lisa Richwine; editing by Lisa Von Ahn and Tim Dobbyn)
By Lisa Richwine