The U.S. regulators announced on Wednesday that a new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug.
Eli Lilly’s Zepbound, or tirzepatide, was approved by the U.S. Food and Drug Administration. In a recent study, the drug helped dieters lose about a quarter of their body weight, which is approximately 60 pounds (27 kilograms).
Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk’s Wegovy, a high-dose version of its diabetes treatment Ozempic.
The FDA approved Lilly’s drug for people who are considered obese, with a body mass index of 30 or higher, or those who are overweight with a related health condition, like high blood pressure, high cholesterol, or diabetes. The FDA mentioned that the drug should be paired with a healthy diet and regular exercise.
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At least 100 million adults and about 15 million children in the U.S. are considered obese.
The drugs tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that regulate appetite and the feeling of fullness, which are released after eating. Both drugs imitate a hormone called glucagon-like peptide-1, known as GLP-1. Tirzepatide targets a second hormone, called glucose-dependent insulinotropic polypeptide, or GIP.
Zepbound appears to spur greater weight loss than Wegovy. Approved for chronic weight management in 2021, Wegovy helped people lose about 15 percent of their body weight, or 34 pounds (15.4 kilograms).
Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital in Boston, called the new drug “the most highly efficacious drug ever approved for the treatment of obesity.”
Tirzepatide and semaglutide have been in such high demand that their manufacturers have struggled to keep up. Both drugs have been listed on the FDA’s drug shortage site for months. All strengths of tirzepatide are currently listed as available, but a company spokesperson said that could vary by location and demand.
The new weight-loss drug has side effects such as vomiting, nausea, diarrhea, constipation, and other gastrointestinal problems. In a recent trial, about 10 percent of people taking tirzepatide dropped out of the study due to such problems.
While experts celebrated the approval of Zepbound, they expressed concern that it wouldn’t necessarily mean greater access to the drug, which has been prescribed “off-label” to help people lose weight.
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Eli Lilly and Co. stated that the list price for the drug will be about $1,000 a month, the same as Mounjaro. Medicare is prohibited from covering drugs specifically for weight loss.
Kelly Burns, 50, of St. Petersburg, Florida, lost nearly 100 pounds (45 kilograms) using tirzepatide after joining a study of the drug to treat obesity in 2021. When testing ended, she struggled, but eventually lost another 50 pounds (23 kilograms).
Now that Zepbound is approved for weight loss, Burns plans to ask her insurance company about coverage. “My whole life is completely different,” she said. Her health measurements improved, and her confidence soared. She wants to stay this way as long as she possibly can.
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