FDA approves Eli Lilly's diabetes drug Mounjaro for obesity under new name, Zepbound

The US Food and Drug Administration approved the type 2 diabetes drug tirzepatide for use in chronic weight management Wednesday, making official the use of a medicine already widely prescribed off-label for weight loss.

The drug, called Mounjaro for diabetes, will be called Zepbound for weight loss, according to a news release from the FDA. Made by Eli Lilly, 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.

Production is already online at one of the two factories in Durham, where Eli Lilly has a manufacturing site.

"It is a miracle drug; it is a lifesaver," said Dr. Catherine Toomer, founder of Total Weight Care Institute.

Even before today's FDA announcement, Dr. Catherine Toomer of Total Weight Care often prescribed Mounjaro off-label due to its weight loss benefits.

"They treat the cause of people's weight gain, and the cause of their weight gain is glucose dysregulation, and that's why diabetes medications work so well," said Toomer.

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.

"Our demand is absolutely huge right now for weight loss," Melissa Illig, White Oak Pharmacy, said.

Obtaining certain weight-loss medications, including the diabetes drug Ozempic, could remain difficult due to ongoing pharmacy backorders.

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 the FDA’s 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 gastrointestinal issues like nausea, vomiting, constipation and diarrhea, the FDA said. 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.

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