On Wednesday, the US Food and Drug Administration officially authorized the use of tirzepatide, a medication already widely prescribed off-label for weight loss, for the treatment of chronic weight management in people with type 2 diabetes.
The medication formerly known as Mounjaro for diabetes will be marketed as Zepbound for weight loss, the FDA announced in a news release. Produced by Eli Lilly, it belongs to a new class of medications that also includes semaglutide, which is called Wegovy for weight loss and Ozempic for diabetes and has seen a sharp increase in popularity in recent years.
Clinical trials using higher doses of Zepbound over a 72-week period demonstrated an average weight loss of more than 20%, which was greater than the results observed with other approved medications.
The FDA approved it for the same indication as Wegovy: individuals who are obese or classified as overweight and have at least one weight-related medical condition, such as heart disease or high blood pressure. Similar to other drugs of a similar nature, it is administered as a weekly shot to patients, and is best taken in conjunction with a diet low in calories and increased physical activity.
“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, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, said in the FDA’s news release. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
According to the FDA, gastrointestinal problems like nausea, vomiting, constipation, and diarrhea are the most common side effects of Zepbound. On the label of the medication, there will be cautions about pancreatic inflammation, gallbladder issues, low blood sugar, acute kidney injury, diabetic retinopathy, or retinal damage in patients with type 2 diabetes mellitus, as well as suicidal thoughts or behaviors.
In a press release, Eli Lilly stated that Zepbound would cost approximately $1,060 a month before insurance. The company also stated in a media briefing that Zepbound would be available on pharmacy shelves following Thanksgiving. The list price of Mounjaro is $1,023 per month, excluding insurance.
The Danish pharmaceutical company Novo Nordisk makes both Ozempic and Wegovy, which are identical medications with different pre-insurance costs, though Wegovy is administered at higher dosages. Wegovy costs $1,349 per month, while Ozempic costs $936 before insurance.
In its press release, Lilly made clear that Zepbound is 20% less expensive than semaglutide when it comes to weight loss.
Lilly said that after consulting with employers—who determine how much to pay for prescription drugs through the insurance plans they offer their staff—it decided on the 20% lower list price.
“They said that the list price was something that was a factor in their decision to expand access to people who need these medications,” Mike Mason, president of Lilly Diabetes and Obesity, told reporters Wednesday.
Patients who are prescribed these medications may still have trouble getting insurance coverage, and it’s unclear how much of Zepbound will be covered. Currently, obesity medications are not covered by Medicare or Medicaid.
If a patient’s plan covers Zepbound, Lilly said it will offer a savings card that will allow them to get the medication for $25 for a one- or three-month prescription; if not, the savings card will allow them to pay $550 for a one-month prescription.
In order to reduce appetite, increase feelings of fullness, and stimulate the release of insulin, tirzepatide mimics these hormones. It specifically targets GLP-1 and GIP hormone receptors, whereas semaglutide only targets GLP-1.
The medications have all experienced supply shortages at different times. Novo Nordisk has even restricted the lower dosages of Wegovy that are prescribed to new patients in order to prioritize the supply of the medication’s higher doses for those who are already taking it. According to studies, if patients stop taking their medications, they may gain back some of the weight they lost.
Even though all dosages of Mounjaro are currently marked as available, the drug is still listed as shortage by the FDA. As the use of the medications has increased, Lilly and Novo Nordisk have both made significant investments to increase the manufacturing of the medications.
During the Wednesday press briefing, Eli Lilly CEO David Ricks cited significant events in the history of the pharmaceutical behemoth as forerunners to the 1986 launch of Prozac and the first commercial insulin over a century ago, referring to them as medical revolutions.
“Before Prozac, patients suffering from depression were essentially told they seem sad, and to try to be a little bit happier, as if they weren’t working hard enough to be happy,” Ricks said. “Today we’re at the beginning of another exciting time in Lilly’s long and distinguished history of making innovative medicines with the approval of Zepbound.”
