Lap-Band wins approval from FDA, trumps weight loss drugs

Lap-Band wins approval for use in more patients

Lap-Band, the silicone device wrapped around the upper portion of the stomach, has been approved by federal health officials for use in a larger number of patients.

Allergan Inc.'s product was originally allowed to be used only for obese patients, but now the U.S. Food and Drug Administration says the company can market Lap-Band to patients who are not severely overweight.

Some 600,000 people have already benefited from their gastric banding product, Allergan said. The device is inserted via laparoscopic surgery. It wraps and tightens the stomach so that a small pouch is created by the band. The small pouch is filled with food more quickly and gives the patient the feeling of fullness more quickly and less hunger over time.

Lap-Band was previously approved for those with a body mass index (BMI) of 40 and above or a BMI of 35 plus high blood pressure or diabetes. With the new ruling, Allergan can now pitch the product for those with a BMI of 30 and above plus one weight-related condition.

In its decision, the FDA said said the product "may have a potential to significantly impact" obesity-related medical conditions, citing a study of 143 patients that demonstrated "statistically significant improvement" within a year of surgery. The review noted that the data shows those patients' weights were stable even beyond 12 months.

Meanwhile, obesity and weight loss drugs are not having much success with the FDA. Takeda Pharmaceutical and Orexigen Therapeutics' Contrave drug was rejected by the agency on safety concerns.

Abbott's Meridia was also ordered to be pulled out by the FDA due to high stroke or heart attack risk. Recent treatments for obesity seems to be shifting from weight loss drugs to gastric banding products like Lap-Band.

Posted by George Daniels on Friday February 18 2011, 3:11 AM EDT. Ref: WSJ. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0