Allergan Seeks Broader FDA Approval for Weight-Loss Implant
The company already sells a stomach band -- a permanent implant placed around the upper portion of the stomach to reduce the amount of food that can be ingested -- that the U.S. Food and Drug Administration approved for use by very obese patients back in 2001. According to documents released Wednesday, Allergan has applied for FDA approval to expand the use of the band for those who are less obese.
The device, called Lap-Band, is currently approved for weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or with a BMI of at least 35 if the patient also has one or more severe health problems.
BMI is a measure of body fat based on height and weight. A normal BMI is between 18.5 and 24.9, according to the NIH. People with BMIs between 25 and 29.9 are considered overweight, while those with BMIs of 30 and over are obese. For example, a person who is 5 feet, 8 inches, and weighs about 144 pounds has a BMI of 22. Weights of 197 pounds, 230 pounds or 262 pounds would mean that person would have a BMI of 30, 35 or 40, respectively.
Lap-Band Causes 'Significant Decrease'
Allergan now hopes the FDA will approve the Lap-Band for patients with a BMI of 35 or higher, or with a BMI of at least 30 if the patient has health-related problems. FDA reviewers found the band has indeed proven effective in reducing weight in these less obese patients. In a clinical trial of patients with BMIs ranging from 30 to 40, 80.5% of all implanted patients lost 30% of their excess weight. Nearly 66% of all the patients with the Lap-Band lost at least 50% of their excess weight.
The FDA reviewers agreed "that there was significant decrease in all measures of weight loss." But they added that they had a few questions that they will want to discuss when the advisory panel meets to vote on whether or not to recommend approval Friday.
Concerns include whether the enrolled population in the study represents the greater U.S. population that would be eligible to receive the device and whether the amount of weight loss would be considered clinically meaningful in the lowest BMI patient population.
"Obesity is one of the major public health issues within the United States because of its high prevalence, economic impact and its relationship with several medical conditions," reviewers wrote in the report. Obesity costs the U.S. as much as $147 billion annually in health care. Not only that, but Americans are getting fatter.
The FDA is also reviewing several pharmacological weight-loss options from Vivus (VVUS), Arena (ARNA) and Orexigen (OREX), but with little success so far. With diets and lifestyle changes barely helping, and with little in the way of obesity drugs, the FDA may well end up considering more options like Allergan's Lap-Band.