FDA approves Eli Lilly's diabetes drug Mounjaro for obesity under ...

The US Food and Drug Administration approved the type 2 diabetes drug tirzepatide for use in chronic weight management Wednesday, making official the use of a medicine already widely prescribed off-label for weight loss.

The drug, called Mounjaro for diabetes, will be called Zepbound for weight loss, according to a news release from the FDA. Made by Eli Lilly, it’s part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss, which have skyrocketed in popularity in recent years.

Zepbound was shown in clinical trials to yield more than 20% average weight loss on higher doses over 72 weeks, stronger results than seen with other approved medicines. The FDA cleared it for people with obesity or those characterized as overweight with at least one weight-related health condition, such as high blood pressure or heart disease, the same indication as for Wegovy. Like similar drugs, it’s taken as a shot patients give themselves once a week, and is recommended on top of a reduced calorie diet and increased exercise.

“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.”

The main side effects of Zepbound are gastrointestinal issues like nausea, vomiting, constipation and diarrhea, the FDA said. The drug’s label will contain warnings for inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy, or damage to the eye’s retina, in patients with type 2 diabetes mellitus and suicidal behavior or thinking.

Zepbound will cost about $1,060 per month before insurance, Eli Lilly said in its own news release, and the company said in a media briefing it would be on pharmacy shelves after the Thanksgiving holiday. Mounjaro’s list price, before insurance, is $1,023 per month.

Ozempic and Wegovy, made by Danish drugmaker Novo Nordisk, are also the same drug with different prices before insurance, although Wegovy is given at higher doses. Ozempic costs $936 a month before insurance, while Wegovy is $1,349.

Lilly specifically highlighted in its release that Zepbound costs 20% less than semaglutide for weight loss.

Lilly said it settled on the 20% lower list price after talking with employers, who make payment decisions about medicines through the insurance they provide employees.

“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.

Still, insurance coverage can be difficult for patients who are prescribed these drugs, and how broadly Zepbound will be covered isn’t yet clear. Medicare and Medicaid are currently banned from covering obesity medications.

Lilly said it would offer a savings card for patients with commercial insurance to be able to get the drug for $25 for a one- or three-month prescription, if patients’ plans cover the medicine; if their plan doesn’t cover Zepbound, the savings card would allow them to pay $550 for a one-month prescription.

Tirzepatide works by mimicking hormones that stimulate the release of insulin, increase feelings of fullness and reduce appetite. It targets two hormone receptors, GIP and GLP-1, while semaglutide focuses just on GLP-1.

The drugs have all been in shortage at various points, with Novo Nordisk even limiting the lower doses of Wegovy, which are prescribed to new patients, to prioritize supply of the higher doses for patients already on the medicine. Studies have shown patients may re-gain some of the weight they lost if they stop taking the medicines.

Mounjaro is still listed on the FDA’s drug shortages list, although all doses are currently labeled as available. Both Lilly and Novo Nordisk have been investing heavily in increasing manufacturing of the medicines as their use has soared.

In the briefing with reporters Wednesday, Eli Lilly Chief Executive Officer David Ricks brandished major moments in the pharmaceutical giant’s history as precursors to the introduction of Zepbound, like the first commercial insulin more than a century ago, and Prozac, in 1986, calling them revolutions in medicine.

“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.”