FDA Approves Mounjaro for Weight Loss Under New Name: Zepbound
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In a highly anticipated decision, the U.S. Food and Drug Administration (FDA) has approved a weekly injected version of the type 2 diabetes drug Mounjaro (tirzepatide) for chronic weight management.
The drug, which will be called Zepbound when prescribed for weight loss, won FDA approval for use by adults with obesity, and by adults with overweight and at least one weight-related health issue such as high blood pressure, type 2 diabetes, or elevated cholesterol, the FDA said in a statement. The FDA recommended that patients use Zepbound in conjunction with a reduced-calorie diet and increased physical activity.
“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,” John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research, said in the statement. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
How Do Mounjaro and Zepbound Work?
Tirzepatide, the active ingredient in Zepbound and Mounjaro, is the first drug in a new family of medicines that target two hormones — glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) — that are involved in maintaining healthy blood sugar levels and sending signals of satiety from the gut to the brain.
The type 2 diabetes drug Ozempic and the weight loss drug Wegovy both contain a different active ingredient, semaglutide, which is known as a GLP-1 agonist. These drugs can aid weight loss by copying the action of a hormone that curbs hunger.
In a study published last month in Nature Medicine, tirzepatide helped people with obesity lose an average of 27 percent of their body weight, or about 64 pounds over 72 weeks.
Zepbound Leads to Weight Loss Similar to Bariatric Surgery
“The results seen with tirzepatide are the best seen so far with any anti-obesity medication and are similar to results seen at one year with bariatric surgery,” Adam Gilden, MD, an associate professor and the associate director of the weight management and wellness clinic at the University of Colorado School of Medicine in Aurora, told Everyday Health last month when the findings were published. Dr. Gilden wasn’t involved in the recent study.
A separate study published in 2022 in the The New England Journal of Medicine found that tirzepatide helped people with overweight or obesity lose an average of 21 percent of their body weight over 72 weeks when they didn’t make any lifestyle changes.
What Are the Side Effects of Zepbound?
The most common side effects experienced by at least 5 percent of people taking Zepbound include nausea, diarrhea, vomiting, constipation, abdominal pain, fatigue, and hair loss, drug developer Eli Lilly said in a statement.
Zepbound carries a so-called “boxed warning,” the FDA’s strictest, because of a rare but serious risk of thyroid tumors, the company said. This drug shouldn’t be used by people with a personal or family history of certain thyroid cancers.
How Much Will Zepbound Cost? When Will It Be Available?
The drug will go on sale in the United States by the end of the year with a sticker price of $1,059.87 per month, Eli Lilly said. Many patients will pay much less with insurance coverage and discounts. The company said it will set up a special savings program for the drug to make a one-month supply available for as little as $25 for some people with insurance coverage for Zepbound, and for as low as $550 for people whose insurance won’t cover the drug.
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