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FDA approves Lilly’s diabetes drug Mounjaro for obesity under a new name

The Indianapolis headquarters of Eli Lilly and Company. (Photo Provided/Eli Lilly and Co.)

(CNN) —  The U.S. Food and Drug Administration on Wednesday approved Lilly’s Type 2 diabetes drug Mounjaro for obesity, making official the use of a medicine already widely prescribed off-label for weight loss.

The drug will keep the name Mounjaro for treatment of diabetes and will be called Zepbound for weight loss. It’s part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss, which have skyrocketed in popularity in recent years.

Zepbound was shown in clinical trials to yield more than 20% average weight loss on higher doses over 72 weeks, stronger results than seen with other approved medicines.

The FDA cleared it for people with obesity or those characterized as overweight with at least one weight-related health condition, such as high blood pressure or heart disease, the same indication as for Wegovy.

Like similar drugs, it’s taken as a shot patients give themselves once a week, and is recommended on top of a reduced calorie diet and increased exercise.

“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,” Dr. John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, said in an FDA news release. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

The main side effects of Zepbound are nausea, vomiting, constipation, and diarrhea. The drug’s label will contain warnings for inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy, or damage to the eye’s retina, in patients with type 2 diabetes mellitus and suicidal behavior or thinking.

This is a breaking news story and will be updated.