U.S. offers drugmakers advice on obesity drugs

As more Americans struggle with growing waistlines, U.S. health officials on Wednesday set out their own tips for drugmakers seeking to develop products for people trying to shed pounds.

The U.S. Food and Drug Administration's draft guidelines -- more than 10 years in the making -- aim to help companies develop and test new drugs and devices for treating obesity.

About a third of U.S. adults, or more than 60 million people, are obese and another third are overweight, government statistics show. Nearly a fifth of U.S. children also weigh too much.

The FDA proposed that companies should prove their products can help people lose weight and keep it off for at least a year. It also urged them to study people with a body mass index of at least 30 or those with a BMI of at least 27 with diabetes, heart disease or other weight-related conditions.

BMI is determined by dividing weight by height. People with a score of 25 to 29.9 are considered overweight and those at 30 or higher are considered obese.

"In general, patients should have or be at significant risk for weight-related morbidity and mortality," the FDA said.
The proposed guidelines come as more companies look to enter the U.S. weight-loss sector, which some analysts have said remains untapped.

Overweight individuals are at risk for other, potentially life-threatening problems. In addition to diabetes, high-blood pressure and certain cancers are also possible.

Drugs usually aim to help people lose weight by curbing their appetite or preventing fat absorption. Some devices, such as Allergan Inc.'s Lab-Band, are used in surgical procedures to limit stomach size.

Last week, GlaxoSmithKline Plc won U.S. approval to sell an over-the-counter version of Roche AG's prescription obesity drug, Xenical, called Alli.

Sanofi-Aventis is also awaiting the FDA's ruling on its Acomplia drug, which the agency earlier this week postponed until July.

Although the guidelines are non-binding, drugmakers often rely on them when developing products. Companies may take other approaches as long as they meet legal standards, the FDA said.

They could also help prompt more manufacturers to develop weight-loss solutions.
"There clearly are not enough effective drugs" for overweight patients, Dr. Richard Kahn, chief scientific and medical officer for the American Diabetes Association, told Reuters.