The Food and Drug Administration on Wednesday approved Eli Lilly and Company‘s diabetes drug for weight loss, making it a main rival to Novo Nordisk’s Wegovy.
The Lilly drug, tirzepatide, which is already approved for diabetes management under the name Mounjaro, will be marketed by the name Zepbound.
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“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,” Dr. 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.”
Two in 5 Americans can be diagnosed with obesity, and another roughly 1 in 3 fits the medical definition of overweight, according to the National Institutes of Health.
In trials, non-diabetic recipients of Zepbound lost, on average, 18% of their body weight, the FDA said.
The FDA also said the average weight loss with the maximum recommended dose of Zepbound was 12 pounds more than the key ingredient in Novo Nordisk drugs Ozempic and Wegovy, semaglutide. Zepbound patients also lost between 27 and 29 pounds more on average compared to those solely on insulin.
Novo Nordisk’s semaglutide, found in both Wegovy for weight loss and Ozempic for diabetes, has been a high-return product for the Danish pharmaceutical giant, allowing the company to outperform its expectations for the last two quarters.
When asked about the new competition on the market, a spokesperson for Novo Nordisk told the Washington Examiner that the company supports all “efforts to drive change in how people living with obesity are seen and treated.”
“Obesity is a chronic, progressive, and misunderstood disease that requires long-term medical management,” the Novo Nordisk spokesperson said. “More treatment options to help improve the lives of those living with obesity are good advancements for patients and a testament to the significant unmet need of addressing obesity.”
Leonard Glass, senior vice president of global medical affairs for Eli Lilly’s diabetes and obesity division, said in a press statement on Wednesday that his pharmaceutical company is committed to treating obesity as a disease.
“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice — something that people should manage themselves,” Glass said. “Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
Eli Lilly said the list price of Zepbound will be $1,059.87 for a one-to-three-month supply, which is 20% lower than Wegovy. For those with commercial insurance that covers Zepbound, patients may be able to pay as little as $25 for up to three months but could pay up to $550 if insurance does not cover obesity medicine drugs.
Both semaglutide and tirzepatide have been the subject of recent scrutiny for negative gastrointestinal side effects, including stomach paralysis.
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The FDA noted in its announcement that Zepbound should not be taken by patients with a history of pancreatic inflammation or severe gastrointestinal disease, including stomach paralysis. The advisory also instructs that patients already taking Mounjaro not take Zepbound, which could heighten the risk of complications.
Eli Lilly and Novo Nordisk have told the Washington Examiner that patient safety is their top priority.
