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    Sunday, May 12, 2024

    FDA approves Mounjaro, rebranded as Zepbound, for weight loss

    The U.S. Food and Drug Administration has approved the use of another diabetes drug for chronic weight management in adults, regulators said Wednesday.

    Tirzepatide — Eli Lilly’s diabetes drug approved under the trade name Mounjaro — will be sold under the name Zepbound to be used as part of a treatment for weight reduction and maintenance.

    Its approval comes just over two years after the approval of the weight loss drug Wegovy, a higher-dose version of Novo Nordisk’s diabetes medication Ozempic.

    Zepbound is indicated for adults who are considered obese, or have a body mass index (BMI) of 30 or higher; or those who are overweight (BMI 27 or higher) and who also have another weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

    “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, director of the FDA’s division of diabetes, lipid disorders and obesity, said in a statement.

    “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need,” he added.

    Zepbound — which should be administered by injection under the skin once a week — works by activating receptors of hormones secreted from the intestine to reduce appetite and food intake.

    Its effectiveness was established in two recent clinical trials involving nearly 3,500 participants over 72 weeks, the FDA said.

    In the larger of the two trials, participants’ average body weight was 231 pounds. After receiving the highest approved dosage of Zepbound (15 mg) the average weight loss was about 48 pounds. Those taking the lowest dose (5 mg) lost on average 34 pounds.

    “Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke and diabetes,” Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said in a statement Wednesday. “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management.”

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