It's the 'Most Efficacious Drug Ever Approved for Obesity'

FDA approves Zepbound, new version of diabetes drug Mounjaro
By Newser Editors and Wire Services
Posted Nov 8, 2023 1:25 PM CST
It's the 'Most Efficacious Drug Ever Approved for Obesity'
This image provided by Eli Lilly on Wednesday, Nov. 8, 2023 shows packaging for their new drug Zepbound. The new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, the U.S. Food and Drug Administration announced Wednesday.   (Eli Lilly via AP)

A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, US regulators announced Wednesday. NBC News reports the FDA approved Eli Lilly's Zepbound, or tirzepatide, a drug that helped dieters lose 22.5% of their body weight (or 52 pounds) in its phase 3 clinical trial. Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk's Wegovy, a high-dose version of its diabetes treatment Ozempic, but its results outpace those of all other weight loss medications currently on the market.

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 drug should be paired with a healthy diet and regular exercise, the FDA said. The drugs tirzepatide (in Zepbound and Mounjaro) and semaglutide (in Wegovy and Ozempic) work by mimicking hormones that kick in after people eat to regulate appetite and the feeling of fullness. Both imitate a hormone called glucagon-like peptide-1, known as GLP-1. But Tirzepatide also targets a second hormone called GIP that NBC News reports may help the body break down sugar and fat.

Zepbound appears to spur greater weight loss than Wegovy, reports the AP. Approved for chronic weight management in 2021, Wegovy helped people lose about 15% of their body weight or 34 pounds, according to study results. "This would be the most highly efficacious drug ever approved for the treatment of obesity," says Dr. Fatima Cody Stanford, an obesity medicine expert at Massachusetts General Hospital in Boston. Gastroenterologist Dr. Christopher McGowan tells NBC News Zepbound appears to be able to nearly achieve what bariatric surgery can. "This is a big deal," he adds. While experts lauded approval of Zepbound, they worried that it wouldn't necessarily mean greater access to the drug, which has been prescribed "off-label" to help people pare pounds.

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Touted by celebrities and on social media, semaglutide and tirzepatide drugs have already been in such demand that their manufacturers have struggled to keep up. "Most patients won't be able to afford Zepbound without insurance coverage and many health plans exclude obesity care," said Dr. Katherine Saunders, an obesity expert at New York's Weill Cornell Medicine. Eli Lilly and Co. said the list price for will be $1,060 a month, the same as Mounjaro. Side effects of the new weight-loss drug include vomiting, nausea, diarrhea, constipatio, and other gastrointestinal problems. In the most recent published trial, about 10% of people taking tirzepatide dropped out of the study because of such problems, compared to about 2% of people taking dummy shots. (More Mounjaro stories.)

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