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FDA approves Eli Lilly’s 2 diabetes drug Mounjaro for obesity under new name, Zepbound.

On Wednesday, the US Food and Drug Administration officially authorized the use of tirzepatide, a medication previously routinely used off-label for weight loss, for the treatment of chronic weight control in people with type 2 diabetes.

The medication formerly known as Mounjaro for diabetes will be marketed as Zepbound for weight reduction, the FDA announced in a press release. Produced by Eli Lilly, it belongs to a new family of medications that also contains semaglutide, which is called Wegovy for weight reduction and Ozempic for diabetes and has seen a notable rise in prominence in the last few years.

Clinical trials using larger dosages of Zepbound over a 72-week period demonstrated an average weight reduction of more than 20%, which was greater than the results observed with other licensed medications. The FDA approved it for the same indication as Wegovy: those 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 medications of a similar kind, it is administered as a weekly injection to patients, and is best used in conjunction with a diet low in calories and increased physical activity.

According to a press statement from the FDA, Dr. John Sharretts, head of the Division of Diabetes, Lipid Disorders, and Obesity, stated that obesity and overweight are significant illnesses that can be linked to some of the top causes of mortality, including diabetes, heart disease, and stroke. “Today’s approval addresses an unmet medical need in light of the rising rates of overweight and obesity in the United States.”

According to the FDA, gastrointestinal problems such nausea, vomiting, constipation, and diarrhea are the most common adverse effects of Zepbound. On the label of the medication, there will be cautions about pancreatic inflammation, gallbladder issues, low blood sugar, acute renal injury, diabetic retinopathy, or retinal damage in patients with type II diabetes in addition to thoughts in suicide and behaviors.

In a press statement, Eli Lilly stated that Zepbound would cost around $1,060 a month before insurance. The firm also stated in a media conference that Zepbound will be available on drugstore 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 differing pre-insurance costs, albeit Wegovy is administered at larger dosages. Wegovy costs $1,349 a month, while Ozempic costs $936 before insurance.

In its press announcement, Lilly made clear that Zepbound is 20% less expensive than semaglutide when it comes to weight reduction.

Lilly claimed 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.

Mike Mason, president of Lilly Diabetes and Obesity, told reporters on Wednesday that the company has decided to increase access to these treatments for those in need, citing the list price as one of the factors.

Patients who are prescribed these medications may still have trouble getting insurance coverage, and it’s unclear how much of Zepbound will be reimbursed. Currently, obesity drugs 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 suppress hunger, promote feelings of fullness, and induce 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 supplied to new patients in order to prioritize the availability of the medication’s higher levels 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 now marked as available, the medicine is nonetheless designated as shortage by the FDA. As the usage of the medications has increased, Lilly and Novo Nordisk have both made significant investments to increase manufacture 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.

“Patients about depression had been basically told they seem sad and to try to be slightly happier, as if you were not working hard enough to be joyful, before Prozac is ,” according to Ricks. “With the approval of Zepbound, we are embarking on a new and exciting chapter in Lilly’s illustrious history of developing cutting-edge medications.”



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