Eli Lilly gets FDA nod for Zepbound for chronic weight management

The FDA has approved Eli LIlly's Zepbound for chronic weight management in adults with obesity, in addition to a reduced calorie diet and increased physical activity.

Sandra Levy

11/19/2023

The Food and Drug Administration has given Eli Lilly permission for Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, Type 2 diabetes or high cholesterol) for use, in addition to a reduced calorie diet and increased physical activity.

Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar (glucose) in adults with Type 2 diabetes mellitus.

"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, director of the division of diabetes, Llpid 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."

Approximately 70% of American adults have obesity or overweight, and many of those overweight have a weight-related condition. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adults with obesity or overweight, the FDA noted.

Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide to reduce appetite and food intake. 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.

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