CNN
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The US Food and Drug Administration has officially approved tirzepatide, a type 2 diabetes drug, for chronic weight management. This medication has been widely used off-label for weight loss and is now known as Zepbound for its weight loss indication.
According to a news release from the FDA, Zepbound, formerly known as Mounjaro for diabetes, is part of a new class of drugs, demonstrating strong weight loss results in clinical trials, surpassing those of other approved medicines for more than 20% average weight loss over 72 weeks.
The FDA has cleared Zepbound for people with obesity or those characterized as overweight with at least one weight-related health condition. This includes high blood pressure or heart disease, with the same indication as for Wegovy. Zepbound, like similar drugs, requires patients to administer a weekly self-injection, in addition to adhering to a reduced calorie diet and increased exercise.
Dr. John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, stated, “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. In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
The FDA has identified gastrointestinal issues like nausea, vomiting, constipation and diarrhea as the main side effects of Zepbound. The drug’s label will contain warnings for various health conditions and severe side effects.
Eli Lilly has announced that Zepbound will cost about $1,060 per month before insurance, and it’s expected to be available in pharmacies after the Thanksgiving holiday.
Furthermore, the drugmaker Novo Nordisk’s medications, Ozempic and Wegovy, are also available in the market, albeit at different prices before insurance.
Lilly heralded the introduction of Zepbound as another significant milestone in the pharmaceutical giant’s history, comparable to the breakthroughs achieved with the commercial insulin and Prozac.
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