As more Americans struggle with growing waistlines, U.S. health officials Wednesday set out their own tips for drugmakers seeking to develop products for people trying to shed pounds.
The 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 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 who have weight-related conditions such as diabetes and heart disease.
BMI is calculated as weight in kilograms divided by height in meters. 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.
More room for diet products
The proposed guidelines come as more drugmakers 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.
Drugmakers often rely on guidelines
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.
“Given the large market opportunity, the health consequences of no therapy, we were shocked that we could only find 17 companies” with products on the market or in advanced development, Susquehanna Financial Group analysts wrote in a recent research note.
FDA officials first proposed the guidelines in 1996, but they lingered until 2004, when the FDA sought public comments.
The revised version, now on the FDA’s Web site, includes advice on products for children as well as those combining two or more drugs. It also offers guidance for products aimed at patients whose extra pounds result from other medications.
“The use of weight-management products in pediatric patients, as in adults, should be contemplated only after a sufficient trial of lifestyle modification has failed,” the FDA said.
The proposal calls for studies to include a wide variety of patients from different regions and racial backgrounds.
The FDA invited public comment on the proposal but gave no deadline. An agency spokeswoman could not be immediately reached to comment on the guidelines.