Published on November 9, 2023, 12:45 am
The Food and Drug Administration (FDA) has granted approval for Eli Lilly’s popular diabetes drug to be used for weight loss management. This opens up new possibilities for patients seeking additional options in their weight loss journey and could lead to a more widespread use of the drug. The formal FDA approval means that tirzepatide can now be covered by most insurance plans, making it more affordable and accessible to millions of patients. This development is expected to contribute to the growing demand for weight loss drugs like Wegovy and Ozempic.
In 2017 and 2021, Novo Nordisk’s Ozempic and Wegovy, respectively, were approved by the FDA for diabetes and obesity treatment. These drugs use semaglutide as the active ingredient. However, until now, Wegovy has been the only approved drug on the market specifically targeting obesity. Tirzepatide was previously approved under the name Mounjaro for the treatment of type 2 diabetes. It will now be marketed as Zepbound for chronic weight management in adults who are overweight or have obesity along with at least one weight-related condition.
Zepbound is administered through a weekly injection and works by activating two naturally produced hormones in the body to reduce appetite and food intake. While it has already been prescribed off-label for weight loss in patients with obesity, coverage by insurance companies has been limited. The approval from the FDA will change this situation.
Obesity and being overweight are serious health conditions that are associated with leading causes of death such as heart disease, stroke, and diabetes. According to John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, “Today’s approval addresses an unmet medical need” given the increasing rates of obesity and overweight in the United States.
Zepbound is expected to be available in the U.S. by the end of this year in six different doses. The list price for a month’s supply is $1,059.87, making it a direct competitor to Wegovy, which costs approximately $1,300 per month. However, it’s important to note that the list price may not reflect the actual out-of-pocket cost to patients. Eli Lilly has plans to implement a commercial savings card program to help reduce costs.
Apart from cost, weight loss drugs also face challenges in terms of accessibility. Private insurers have been reluctant to cover drugs like Wegovy and Ozempic due to their perception as lifestyle or cosmetic medications rather than essential treatments. While Ozempic is primarily approved for diabetes treatment, it is sometimes prescribed off-label as an anti-obesity drug. Additionally, Medicare is prohibited by federal law from covering weight loss drugs.
Mike Mason, Executive Vice President and President of Lilly Diabetes and Obesity, acknowledged that there are still many hurdles preventing individuals with obesity from accessing appropriate treatments for significant weight loss. He stressed the importance of expanding access to these medicines and expressed Lilly’s commitment to working with healthcare providers, government agencies, and industry partners to ensure that individuals who could benefit from Zepbound can access it.
In a large clinical trial involving patients without diabetes, tirzepatide demonstrated promising results. When combined with a reduced-calorie diet and increased physical activity, patients lost an average of 18% of their body weight compared to those on a placebo.
According to the FDA, about 70% of American adults are either overweight or have obesity. Losing 5%-10% of body weight through diet and exercise has been shown to reduce the risk of cardiovascular disease in individuals with obesity or who are overweight.
Overall, this FDA approval for Eli Lilly’s tirzepatide marks an important milestone in the field of weight loss management. With its potential for wider use and improved affordability through insurance coverage, more individuals struggling with weight-related conditions may have access to effective treatments. However, broader efforts are still needed to address the barriers preventing people with obesity from accessing these medications and achieving significant weight loss.