The Food and Drug Administration (FDA) granted approval on Wednesday for Eli Lilly’s Mounjaro, or tirzepatide, to be used in the treatment of obesity and chronic weight management. This GLP-1 agonist has been shown to achieve weight loss results similar to bariatric surgery. It will now be available for weight loss as Zepbound.
Of the decision, the FDA’s director of the division of diabetes, lipid disorders and obesity, Dr. John Sharretts said, “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. In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
What is Tirzepatide?
Tirzepatide, known under the brand name Mounjaro, was approved for the treatment of Type 2 diabetes in May 2022. The drug has since been used off label for weight loss and weight management, similarly to other medications like Wegovy and Ozempic. It works by activating two hormones that slow gastric emptying, leading to feeling full longer and quieting “food noise.”
According to New York endocrinologist Barrie Weinstein, MD medical director of Well by Messer, this approval is more than warranted. “I have been eagerly awaiting the FDA approval of Tirzepatide for weight loss since it was released during the summer of 2022 with a diabetes indication,” she explains. “I have seen remarkable weight loss results with off-label use. There is a current shortage of both Wegovy and Saxenda, so I am very excited to have another medication to add to my toolbox.”
A New Name
Eli Lilly says they plan to release the drug under the name Zepbound. Like Mounjaro, it is administered via weekly injection, with dosing gradually increasing over four to 20 weeks.
Baton Rouge, LA obesity expert and senior director of clinical product strategy at Ro, Raoul Manalac, MD says the approval may lead to greater insurance coverage and gives patients another option to help achieve their weight and health goals. “The clinical trials of Zepbound indicate that average weight loss results may be even more significant than Ozempic or Wegovy, with patients losing as much as 25 percent of their body weight, broadening the accessibility and efficacy of this life-changing class of medications for patients who need them.”
A Changing Landscape
Obesity and lipid specialist Dr. Spencer Nadolsky, who serves as medical director for WeightWatchers says the approval of Zepbound will benefit countless people. “This is a significant development in the field of obesity treatment with the FDA recognizing the impact found in weight loss for those prescribed this medication. Tirzepatide is by far the most powerful drug we have to date for weight management, with an average body weight loss achievement demonstrated over 20 percent when taken for 72 weeks and even more when taken longer.”
He notes that this is encouraging for clinicians as well. ”It is also important to note— this is not a quick fix, as FDA labeling across all GLP-1 agonists for weight management states— behavior modifications are still necessary to incorporate alongside clinical interventions for weight loss and weight management,” he adds. “This includes specific attention to a nutrient-dense diet, fluids, and movement like resistance training.”
Clinical Trials
This approval was granted based on results of two late-stage trials conducted over a 72-week period. Zepbound was found to be effective for managing weight in adults with obesity or overweight and weight-related conditions when combined with a reduced-calorie diet and increased physical activity.
The studies involved 2,519 patients who received Zepbound at doses of 5 mg, 10 mg, or 15 mg once weekly, as well as 958 patients who received a placebo once weekly, demonstrated significant weight reduction after 72 weeks. Patients on Zepbound experienced greater weight loss and a higher percentage achieving at least 5 percent weight reduction compared to those on placebo. In one of the trials, those receiving the highest dose lost an average of 18 percent of their body weight if they didn’t have diabetes and 12 percent if they had type 2 diabetes.
Potential Side Effects
According to the FDA, the same side effects and warnings that have been issued about Mounjaro exists. Zepbound may cause side effects like nausea, diarrhea, and stomach discomfort. It has also been linked to thyroid tumors in rats, but this has not been found in humans. It may also lead to pancreas and gallbladder problems.
Will there be a Zepbound savings card?
The price of the drug is $1,060 monthly. To make it more accessible, Eli Lilly is introducing a savings card program. For those with commercial insurance coverage, the card will lower the price to $25 for a 1-month or 3-month prescription. For those with commercial insurance without Zepbound coverage, the prescription will cost $550 a month. The savings card program will be available as soon as the drug is available in U.S. pharmacies.
