FDA Approves Eli Lilly’s Zepbound for Chronic Weight Management

Pictured: Eli Lilly's office in Indianapolis/iStock, jetcityimage

Pictured: Eli Lilly's office in Indianapolis/iStock, jetcityimage

Eli Lilly announced Wednesday that the FDA has approved its Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or excessive weight with at least one weight-related condition, such as hypertension, type 2 diabetes or high cholesterol.

Tirzepatide, the active ingredient in Zepbound, is already approved in Lilly’s injectable type 2 diabetes drug Mounjaro. Lilly contends that Zepbound is the first and only approved treatment activating two incretin hormone receptors, GIP and GLP-1, to tackle an underlying cause of excess weight.

The FDA approved Mounjaro to treat type 2 diabetes in May 2022. However, it has been used off-label for weight loss.

In Wednesday’s FDA approval announcement, the regulator warned that Zepbound “should not be used in combination with Mounjaro or a GLP-1 receptor agonist” as “the safety and effectiveness of coadministration of Zepbound with other medications for weight management have not been established.” 

Zepbound’s approval for weight loss was based on two randomized, double-blind, placebo-controlled Phase III trials, SURMOUNT-1 and SURMOUNT-2, which measured weight reduction after 72 weeks in 2,519 patients. In both trials, patients who received Zepbound at all three dose levels—5 mg, 10 mg or 15 mg—experienced a “statistically significant” reduction in body weight compared to those who received placebo, and greater proportions of patients who received the drug achieved at least 5% weight reduction compared to placebo, according to the FDA.

The regulator noted in its approval announcement that losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in obese or overweight adults.

“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 Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, 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.”  

Wednesday’s FDA approval of Zepbound for weight loss now puts Lilly in a lucrative duopoly. Novo Nordisk’s Wegovy (semaglutide) and Lilly’s Mounjaro already drove blockbuster sales in the third quarter. Goldman Sachs analysts forecast that the obesity drug market could reach $100 billion, with the Novo-Lilly duopoly capturing about 80% of the market share by 2030.

Lilly aims to make Zepbound available in the U.S. by the end of the year with six dosage forms available. The drug will have a list price of $1,059.87, which the company contends is around 20% lower than semaglutide’s 2.4 mg injection. It is also under regulatory review for weight loss in China, the U.K. and Europe.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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