Eli Lilly’s Zepbound gets FDA approval for weight loss
Eli Lilly & Co.’s diabetes drug to treat obesity wins U.S. approval. The drug, Zepbound, will cost slightly more than the diabetes version of the same drug, Mounjaro. Madison Mueller reports on “Bloomberg Markets: Close.”
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The weight-loss drug Wegovy can help people with heart disease avoid another heart attack or stroke, according to a study presented Saturday at a medical conference.
The study, funded by the drug’s maker Novo Nordisk, found that patients with a body mass index (BMI) high enough to be considered “overweight” or “obese” had a 20% lower risk of heart disease and stroke. %. The same benefit has previously been shown in high-risk people with type 2 diabetes and a relatively high BMI.
All study subjects were already receiving standard-of-care treatment, so the benefits went beyond what people taking medications for high blood pressure and high cholesterol might expect.
“Now we notice this when we have patients who are overweight and obese but don’t have diabetes,” said Dr. Michael Linkoff, a cardiologist at the Cleveland Clinic who led the study. The study was also published in New England Journal of Medicine.
The latest class of weight-loss drugs has health benefits not seen in previous drugs, study results suggest. Several early weight-loss drugs, including fenfen and sibutramine, were withdrawn from the market because they caused cardiovascular problems.
Linkoff and others say the study’s biggest impact may come from insurance coverage.
“This is a trial that will change the way reimbursement is done,” said Dr. Eric Topol, a cardiologist and founding director of the Scripps Research Translational Institute.
He said it would be difficult for the Centers for Medicare and Medicaid Services (CMS) to reject a drug that could reduce the chances of another heart attack or stroke in high-risk people. Currently CMS and many private insurance plans do not cover the cost of weight loss drugs.
But Topol worries that Wegovy’s high cost, which retails for more than $1,300 a month, will “break the bank” once Novo Nordisk resolves the supply problems that have plagued it for the past two years.
Linkov said that this issue would be discussed another day.
“Half the battle is proving the science. The other half the battle is having to implement what has been proven,” he said. “You have to start by proving it. That’s what we’re doing now, in a convincing way.”
Provide health benefits
In the past, weight loss drugs combined with lifestyle changes only helped people lose about 5 to 10 percent of their weight.
Although weight gain is thought to increase health risks, the kind of long-term weight loss (15 to 20 percent of body weight) that would provide substantial medical benefit is out of reach for the vast majority of people unless they choose surgical bariatric therapy. Operation.
But another drug called Zepbound, approved this week by Wegovy and Eli Lilly, promises even greater weight loss. Research shows that when combined with regular exercise and a healthy diet, the highest doses of Wegovy can help people lose about 15% of their body weight. The maximum dose of Zepbound exceeds 20%. (The new study only tested Wegovy, not Zepbound, so it’s unclear whether Zepbound has the same heart benefits.)
In this study, participants only lost an average of about 9% of their body weight, but still experienced significant benefits. Linkoff said he doesn’t think they’ve lost more because the study was led by cardiologists like himself rather than by obesity medicine experts who prioritize lifestyle changes.
The relatively small weight loss and rapid reduction in strokes and heart attacks suggest that Wegovy’s health benefits come as much from the weight loss as from the drug itself, Linkov said. In study participants, the drug lowered blood pressure and signs of inflammation, and in laboratory studies it had a direct effect on heart muscle as well as blood vessel walls and arteries, which may explain the reduction in strokes and heart attacks, he said.
Topol said he was most impressed by the drug’s improvements in metabolic health. Half of the participants who took the placebo had abnormal blood sugar levels at the end of the trial, compared with only 21% of those who took the drug.
“This does have a very profound impact on preventing people from developing diabetes, which is encouraging,” he said.
Wegovy is the brand name for the weight loss drug semaglutide, which was tested in patients 45 and older with cardiovascular disease and a BMI of 27 or higher but no history of diabetes. More than 17,000 people from 41 countries were randomly assigned to receive weekly injections of 2.4 mg of semaglutide or a similar placebo and were followed for an average of more than three years.
Results from the SELECT trial, called “Semaglutide and Cardiovascular Outcomes in Nondiabetic Overweight or Obese Patients,” will be presented Saturday at the American Heart Association’s 2023 Scientific Sessions in Philadelphia.
“We do believe that the results from SELECT have tremendous value – not just for people living with obesity, but also for healthcare professionals, policymakers, and it has the potential to fundamentally change the way we think about obesity as a a serious chronic disease, not just a lifestyle condition,” Dr. Martin Holst Lange, Novo Nordisk’s executive vice president of development, said in an interview.
The company is also testing semaglutide in people with relatively high BMIs and at risk for liver disease, peripheral artery disease and arthritis.
Recently, an independent reviewer stopped a trial in patients with diabetes and chronic kidney disease prematurely because it was so effective that continuing to give participants a placebo would have been considered unethical. Detailed results from the trial will be published early next year.
Experts say the biggest missing piece in public understanding of the new class of drugs semaglutide and incretins is their long-term effects.
The SELECT trial is the longest trial to date in people without diabetes. It followed people for 40 months, but the drugs are taken for life, just like high blood pressure and cholesterol-lowering drugs.
Early studies from Novo Nordisk and others suggest people regain weight after stopping the medication.
Topol said he worries about what will happen when people at high risk for heart disease no longer want or can afford weekly injections of Wegovy.
“For all we know,” he said, “the rebound could be worse.”
Please contact Karen Weintraub at [email protected].
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