Regulators say a new version of a popular diabetes medicine can be sold as a weight-loss drug in the U.S. The Food and Drug Administration on Friday approved Wegovy.
It's a higher-dose version of a diabetes drug from the Danish company Novo Nordisk.
In company-funded studies, participants taking Wegovy had an average weight loss of 15%, which is about 34 pounds.
Participants lost weight steadily for 14 months before plateauing.
In a comparison group getting dummy shots, the average weight loss was about 2.5%.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a news release. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
The FDA said the dose of the medication must be increased gradually once weekly to 2.4 mg over 16 to 20 weeks to reduce gastrointestinal side effects.
More than 100 million adults in the U.S. are obese.
Like other weight-loss drugs, it's supposed to be used along with exercise and a healthy diet.