Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes, has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
The Food and Drug Administration’s long-awaited approval of the drug, which will be marketed under the name Zepbound for obesity, is a major milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages.
“In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need,” 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.
Novo’s Wegovy (like its sister diabetes drug Ozempic) targets receptors of the GLP-1 hormone, and has shown in trials to cut around 15% of people’s body weight. Meanwhile, Zepbound, which targets both the GLP-1 and GIP hormones, has shown up to 21% weight loss in trials.
The drug, first approved for diabetes last year, is rapidly becoming Lilly’s top-selling product. The company made about $3 billion in revenue on tirzepatide in the first three quarters of this year, and the treatment’s long-term potential has made Lilly the most valuable pharmaceutical company in the world, with a market capitalization of nearly $600 billion.
Lilly is conducting further clinical trials enrolling patients with obstructive sleep apnea, chronic kidney disease, and osteoarthritis, part of an effort to further establish the value of its medicine — and convince payers and insurers to loosen restrictions on patient access.
Both Mounjaro and Wegovy carry list prices in excess of $1,000 a month. Soaring demand for the medicines has led payers to put up barriers to access, often requiring patients to try cheaper drugs before going on GLP-1 medicines or refusing to pay for them outright.
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