“Obesity and overweight are serious conditions that can be linked to some of the leading causes of death such as heart disease, stroke and diabetes,” John Sharetts, director of the FDA’s Division of Diabetes, Lipid Disorders and Obesity, said in a statement. “In light of rising rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Leonard Glass, Lilly’s senior vice president, said in a statement that obesity “is often viewed as a lifestyle choice” despite scientific evidence to the contrary. “Lily aims to dispel misconceptions about this disease and change the way it can be managed,” he said.
The approval, while widely expected, is a watershed moment for Lilly and a society struggling with the high costs of caring for obese patients. Zepbound would give patients another powerful weight-loss tool, but it also forces employers and insurers to consider covering the cost of an expensive drug that patients may need to take long-term to keep their weight off.
Tirzepatide is part of a new generation of appetite suppressants that, despite sometimes unpleasant side effects, have become a sensation among Hollywood celebrities – and people who have long struggled to lose weight and keep it off.
The revolution in weight loss treatment comes at a pivotal time for public health in the United States. More than 14 percent of adults in the United States have diabetes and nearly 42 percent are obese, according to the Centers for Disease Control and Prevention. More Americans are dying earlier because of weight-related chronic diseases, according to Washington Post analysis.
Louis Aron, director of the Center for Weight Management and Metabolic Clinical Research at Weill Cornell Medicine, said drugs like tirzepatide will be critical to treating obesity and improving broader health outcomes. “People will live longer lives,” Aaron said.
What you need to know about Zepbound, the latest weight loss drug
Tirsepatide is the second of a new generation of drugs approved for the treatment of type 2 diabetes and obesity. The FDA approved Novo Nordisk’s Ozempic for diabetes and Wegovy for obesity in 2017 and 2021, respectively, and both drugs use the active ingredient semaglutide. Lilly and Novo are investigating how their new molecules can treat a range of conditions, from alcohol addiction to cardiovascular disease.
Lilly has set a list price for Zepbound at about $1,060 for a one-month supply, slightly higher than Mounjaro’s $1,020 but approximately 20 percent less than Wegovy, its most direct competitor, which costs around $1,350 per month. Mike Mason, Lilly’s executive vice president, said Wednesday that the company consulted with employers and set a lower price for the drug to encourage companies to expand access.
Lilly also said it is introducing a savings program that will allow certain patients with commercial insurance to pay as little as $25 for a one- or three-month prescription. People whose insurance does not cover Zepbound may be eligible for a 50 percent discount off the list price.
Novo Nordisk said that about 80 percent of patients who take Wegovy and have commercial insurance pay $25 or less a month, and that those whose insurance doesn’t cover the drug can get $500 off the $1,350 list price for up to year.
As with Wegovy, FDA approval of Zepbound for obesity is likely to increase demand, which manufacturers are struggling to meet. Mounjaro’s undersupply weighed on its third-quarter earnings, even though it brought in about $1.3 billion in sales. The FDA lists all of Mounjaro’s strengths as available, but the drug remains on the shortage list while the agency verifies that Lilly has adequate supplies.
Dave Ricks, Lilly’s CEO, said Wednesday that the company expects Zepbound to be available to patients by the end of the year. “Are there scenarios where we don’t support this? Of course, he said. “But we’re poised for a big, bold launch.”
Shortages of tirzepatide and semaglutide have allowed specialty pharmacies to make copies of the patented products while they are in short supply. That, in turn, is fueling a new industry of clinics and telehealth providers that sell pharmacy-made versions for a fraction of the drugs’ list price, as well as websites that peddle unregulated, research-grade weight-loss chemicals.
Lilly earlier this year began production at a manufacturing facility in North Carolina, helping to increase the supply of autoinjectors used to administer Mounjaro.
“We continue to believe that supply will be a limiting factor for the launch of Mounjaro/tirzepatide over the next several years,” Goldman Sachs analysts wrote in a research note last week.
Lilly’s shares rose more than 3 percent on Wednesday and are up more than 60 percent so far this year, giving it a stock market value of nearly $590 billion — the largest of any U.S. drugmaker.
Novo Nordisk, Eli Lilly raise cash from weight loss drugs
Tirzepatide is injected once a week and communicates with receptors in areas of the brain that help regulate appetite, recruiting two naturally produced hormones in the gut and causing a feeling of fullness. This effect – similar to that of semaglutide – has helped many patients lose weight to an unprecedented degree.
Mounjaro was first approved by the FDA in 2022 to help control blood sugar. The weight-loss drug’s approval was spurred by the results of key clinical trials published earlier this year, including one that showed tirzepatide helped overweight or obese participants lose at least a quarter of their body weight when combined with with a low-calorie diet, exercise and weekly counseling.
Diana Tiara, medical director of UC San Francisco’s weight management program, compared the drug’s effects to those seen in gastric sleeve surgery. “High rates of weight loss are really powerful,” Tiara said of tirzepatide.
She cautioned that the drug, while groundbreaking for treating obesity, should not be used solely to promote short-term extreme weight loss to the exclusion of healthy eating habits. “It should be used to calm those hunger pangs and focus on nutrition and lifestyle, like exercise,” Tiara said.
Amid the drug craze, access to the shots has been a public challenge — because of persistent shortages and high prices for uninsured patients, and because some insurers don’t cover weight-loss drugs.
An epidemic of chronic disease is killing us all too soon
Weight loss drugs are still often seen as cosmetics rather than vital long-term treatments like drugs prescribed for hypertension, doctors say. Federal law prohibits Medicare from covering weight loss drugs, excluding a large portion of potential patients.
Novo Nordisk said last week that most major drugstore managers and health plans cover Wegovy for obesity, giving about 50 million people access to the drug through insurance.
Although many doctors already prescribe Mounjaro off-label to treat obesity, more will now feel more comfortable doing so, said Aronne of Weill Cornell Medicine, who consults with drug companies.
“It will absolutely expand access,” Aronne said of the FDA’s decision.
It remains to be seen how Lilly’s Zepbound will compete with Novo’s Wegovy and its higher list price. When the list price of a drug is higher, manufacturers can offer a larger discount that is attractive to buyers of the drug such as pharmacy managers.
With Zepbound’s prices significantly lower than Wegovy’s, Lilly will not be able to offer the same level of discount to drug buyers. Instead, Lilly is betting on winning over more employers.
That could be key to the obesity market, where employers choose to cover the condition, writes David Reisinger, an analyst at investment firm Leerink Partners. in a research note on Wednesday. Lilly, he wrote, “wants to be able to drive access to the obesity market.”