The U.S. Food and Drug Administration on Wednesday approved a new version of the type 2 diabetes drug tirzepatide for use in chronic weight management, officials said.
Regulators previously approved the drug, from Eli Lilly, for treatment of diabetes under the name Mounjaro. The version approved for weight loss is called Zepbound.
Officials said Zepbound was approved for adults who are obese or overweight and who have at least one weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol.
John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said Wednesday in a statement that the approval “address an unmet medical need,” pointing to “increasing rates of both obesity and overweight.”
“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,” he said.
We approved a new injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol), to use in addition to a reduced calorie diet and increased physical… pic.twitter.com/5gCbvm7ck9
— U.S. FDA (@US_FDA) November 8, 2023
The Centers for Disease Control and Prevention estimates that one in three adults in the U.S. struggle with obesity. About 70% are obese or overweight, and many of those have weight-related conditions, according to the FDA.
The agency’s approval came after a study found that people with obesity or excess weight who took Zepbound while also taking steps to improve their diets and get exercise lost as many as 48 pounds in 72 weeks, according to Eli Lilly. The company said that people who used the drug at its lowest dose had lost 34 pounds by 72 weeks compared to 7 pounds for those who took a placebo.
“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” Dr. Leonard Glass, senior vice president of global medical affairs for Lilly Diabetes and Obesity, said Wednesday in a statement.
He added, “Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
Eli Lilly expects Zepbound to be available in the U.S. by the end of the year.
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