Nov. 8, 2023 -- The FDA on Wednesday approved an injection drug for chronic weight management for adults with obesity or those who are overweight and have at least one weight-related condition, such as high blood pressure or high cholesterol.
The FDA approved Zepbound (tirzepatide) for use in addition to a lower-calorie diet and more exercise.
Tirzepatide is the active ingredient. It is already approved as Mounjaro for use, along with diet and exercise, to improve blood sugar in adults with type 2 diabetes mellitus, the FDA said in a press release.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Consumers this year have made Wegovy, for obesity and overweight, popular, along with Ozempic, for diabetes.
Some 70% of adults are obese or overweight, and many who are overweight also have at least one weight-related condition, the FDA says. Adults with obesity or overweight can lower their risk of cardiovascular disease by losing 5% to 10% of their bodyweight by eating right and exercising.
“Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake,” the FDA said. “Zepbound is administered by injection under the skin once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dosages of 5 milligram (mg), 10 mg or 15 mg once weekly. The maximum dosage of Zepbound is 15 mg once weekly.”
Zepbound was tested for efficacy in two randomized, double-blind, placebo-controlled trials.
Side effects can include nausea, diarrhea, vomiting, constipation, abdominal discomfort, and pain.