Diabetes Drug Mounjaro Approved by FDA for Weight Loss, To Be Sold Under the Name Zepbound

On November 8, the U.S. Food and Drug Administration approved the type 2 diabetes drug tirzepatide for chronic weight management. The announcement made it official to use a medicine already widely prescribed off-label for weight loss.

A New Version of Diabetes Drug

The drug is known as Mounjaro for diabetes, but it will be called Zepbound for weight loss. Made by pharmaceutical company Eli Lilly, the new medication is part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss.

Obesity and being overweight are serious conditions that can be linked to some of the leading causes of deaths, like stroke, diabetes, and heart disease, according to FDA's Division of Diabetes, Lipid Disorders, and Obesity director Dr. John Sharretts. Due to increasing rates of both obesity and being overweight in the U.S., the approval of the new drug is believed to address an unmet medical need.

In its news release, Eli Lilly highlighted that Zepbound costs 20% less than semaglutide for weight loss. It settled on that range after talking with employers, as they make payment decisions about medicine through the insurance they provide to their employees.

As reported by Lilly Diabetes and Obesity President Mike Mason, the 20% lower list price was something they considered in their decision to expand access to people who need these drugs. However, insurance coverage can still be difficult for patients prescribed these drugs, while the scope of covering Zepbound is also unclear.

Mounjaro is still included in the FDA's drug shortages list, although all doses are currently labeled as available. Both Lilly and Danish drugmaker Novo Nordisk, the maker of Ozempic and Wegovy, have been heavily investing in the increase of manufacture of the medicines since their use has soared. Eli Lilly Chief Executive Officer David Ricks flaunts the history of their company as precursors to the introduction of Zepbound, like the first commercial insulin over a century ago, and Prozac in 1986.

How Does Tirzepatide Work?

Tirzepatide works by imitating the hormones that stimulate insulin release, leading to increased feelings of fullness and reduced appetite. This drug targets two hormone receptors, GIP and GLP-1, while semaglutide focuses only on GLP-1.

Zepbound was shown in clinical trials to yield over 20% average weight loss on higher doses over 72 weeks. These results are more robust than seen with other approved drugs. The FDA cleared it for people with obesity or those categorized as overweight with at least one weight-related medical condition. Just like other drugs, it is taken once a week as a shot, recommended on top of a reduced-calorie diet and increased exercise.

This drug has its main side effects, which include diarrhea, constipation, vomiting, and nausea. Its label will also include warnings for diabetic retinopathy, acute kidney injury, low blood sugar, gallbladder problems, inflammation of the pancreas, or damage to the retina in patients with type 2 diabetes mellitus.