The approval gives patients with obesity another tool and opens the door to a potentially much wider use.
Tirzepatide was previously approved to treat type 2 diabetes under the name Mounjaro. The drug will be marketed as Zepbound for chronic weight management in adults who have obesity or are overweight with at least one weight-related condition such as high blood pressure or heart disease.
Formal FDA approval means tirzepatide could be covered by most insurance plans, making it more affordable for millions of patients. It's part of a new class of drugs like Novo Nordisk's Wegovy and Ozempic that have skyrocketed in popularity in recent years.
Zepbound is a weekly injection that works by activating two naturally produced hormones in the body to reduce appetite and food intake.
"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," John Sharretts, director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, said in a statement. "In light of increasing rates of both obesity and overweight in the United States, today's approval addresses an unmet medical need."
Zepbound is expected to be available in the U.S. by the end of the year at a list price of about $1,060 per month, Eli Lilly said. It's a direct competitor to Wegovy, which costs about $1,300 per month. Mounjaro's list price, before insurance, is $1,023 per month.
Like Mounjaro and Zepbound, both Wegovy and its sister drug Ozempic are the same drug, called semaglutide. Ozempic costs $936 a month before insurance, but it's given at a lower dose.
Aside from cost, weight loss drugs face other accessibility challenges.
Private insurers have been unwilling to cover Wegovy and Ozempic because they are viewed as lifestyle or cosmetic medicine and not essential.
Ozempic is only approved as a diabetes treatment, though it's prescribed off-label as an anti-obesity drug. Federal law bars Medicare and Medicaid from covering weight-loss drugs.
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